3M Company Health Care Business 3m Center Recalls
Showing 1-14 of 14 recalls
3M Surgical Clipper Professional 9681
Failure to follow proper charging practices can result in lithium-ion battery degradation, characterized by excessive heat during operation or failure to properly charge. In rare circumstances, battery degradation has been associated with battery venting, which is a rapid release of battery energy.
The firm initiated their field safety action on 02/08/2018 by certified mail to customers and distributors. Larger distributor were notified by email on 02/12/2018. The notices to the distributors stated: "3M is notifying all users of the 3M" Surgical Clipper Professional 9681 of an added product warning, stressing the importance of following proper clipper charging practices as documented in the Model 9681 Clipper instructions for use. Current charging instructions recommend leaving the clipper body in the drop-in charger in between uses. Failure to follow proper charging practices can result in lithium-ion battery degradation, characterized by excessive heat during operation or failure to properly charge. In rare circumstances, battery degradation has been associated with battery venting, which is a rapid release of battery energy. 3M has received two reports of battery venting resulting in minor burn injury. 3M is adding the following product warning to emphasize the importance of proper charging practices: Warning: To avoid potential battery degradation, charge the clipper after each use and store in the drop-in charger stand when not in use. Distributors are being asked to take the following actions: " Identify those customers who have ordered the 3M" Surgical Clipper Professional 9681 or the 3M" Surgical Professional Clipper Blades 9680 beginning January 1, 2016 to date. " Communicate this Field Safety Notice to those customers." The notice to the customer stated the following: "3M is notifying all users of the 3M" Surgical Clipper Professional 9681 of an added product warning, stressing the importance of following proper clipper charging practices as documented in the Model 9681 Clipper instructions for use. Current charging instructions recommend leaving the clipper body in the drop-in charger in between uses. Failure to follow proper charging practices can result in lithium-ion battery degradation, characterized by excessive heat durin
3M Red Dot Electrodes, Radiolucent Monitoring Electrode with Foam Tape, Catalog No. 2244, (3M ID (SKU): 70-2011-8506-6, SAP ID: 7100212989), packaged 10 electrodes per card, 5 cards per pouch, 20 pouches per shipper box, 1,000 electrodes total per shipper box. The 3M Red Dot Radiolucent Monitoring Electrode with Foam Tape 2244 is intended to be used by healthcare professionals for ECG monitoring. This electrode is disposable, intended for single use, and has been tested for up to 3 days wear.
Potential for breakage of the ECG electrode carbon stud from the eyelet.
The recalling firm, 3M Company, issued "Urgent - Medical Device Recall" letters dated 29 September 2021 to the distributors on 10/6/2021. The letter informs them of the issue and instructs them to immediately discontinue distribution of the affected lots and determine if any are in inventory. The affected product is to be destroyed by the distributor. The distributor is to notify any customers who have purchased the affected lots by using the enclosed Customer Letter and Customer Acknowledgment Form provided. The enclosed customer letter to be sent to the distributor's customers is dated 29 September 2021 and informs the customer of the issue. The customer is instructed to screen their facility or other storage locations to ensure all affected lots of the product are identified. They are to immediately cease use of affected lots of product and quarantine it for destruction/disposal. The customer is requested to pass the notification along to all who need to be aware within their organization or to any department where the affected product was transferred.Complete the attached Customer Acknowledgement Form with the following: o Acknowledge that you have read and understood this letter, whether or not you have any affected lots of the 3M" Red Dot" Radiolucent Monitoring Electrodes with Foam Tape, Catalog Number 2244 in stock at your facility; and o Indicate if you have any product in stock and dispose of this material per facility policy. o Email the completed form to 3MFieldSafetyAction@montage72.com. " Complete and return the Customer Acknowledgement Form to 3M even if your stock of affected lots of this product have been exhausted. " To request product replacement for affected lots requiring disposal, contact 3M Health Care Customer Helpline at 1-800-228-3957, option #7 or by email to 3MFieldSafetyAction@montage72.com. If you have questions regarding this matter, please contact your local 3M sales representative or the 3M Health Care Customer Hel
Novaplus Monitoriing Electrode with Foam Tape and Sticky Gel - Product Usage: intended to be used by healthcare professionals for ECG monitoring. 5 electrodes per card; 1 card per pouch; 200 pouches per shipper box (1000 electrodes total).
Corrosion could cause performance failures in the product.
The recalling firm issued customer letters to consignees on 10/7-8/2020. The recalling firm is requesting a returned acknowledgement form from the consignee. Distributors will also be sent a template customer letter and customer acknowledgement so that they may notify their customers. The recalling firm will initiate multiple attempts to follow up with non responders. Customers and distributors are requested to dispose of any products still in their possession.
3M Durapore Advanced, Surgical Tape, Model Numbers: 1590-0, 1590-1, 1590-2, 1590-3, 1591-0, 1591-1, 1591-2, 1591-3, 1590S-1, 1590S-2, 1590B-118, 1590B-136
While the product meets all safety and efficacy criteria, long term exposure of 3M Durapore Advanced Surgical Tape to continuous high moisture clinical applications has not fully met all of 3M s performance expectations. This use environment may cause tape bond failure, leading the tape to not perform as intended. Further, the tape fibers may fray which could be accidentally ingested or aspirated.
The firm initiated the recall by letter on 11/20/2019. The letter explained the failures seen and requested the following actions be taken: 1. Immediately cease use of the product and quarantine it for destruction/disposal. 2. Complete the attached Customer Acknowledgement Form with the following: - Acknowledge that you have read and understood this letter whether or not you have any 3M" Durapore" Advanced Surgical Tape in stock at your facility; and - Indicate if you have any product in stock and dispose of this material per facility policy. - Email the completed form to 3Mhealthcare@montage72.com 3. If there are clinical questions, contact Kimberly Schommer, RN, BSN via the 3M Health Care Customer Helpline at 1-800-228-3957.
3M(TM) Surgical Clipper by Remington(R) REF 9602 The 3M Surgical Clipper Classic, 9602, is intended to remove body hair and head hair from patients in preparation for any medical procedure requiring hair removal.
3M has recently received reports involving the 3MTM Surgical Clipper by Remington, Model 9602, overheating in mobile/field EMS situations while charging from a modified sine wave power inverter.
The firm, 3M Health Care, disseminated their "Field Safety Action" letter dated 1/9/2019 to its customers beginning on 01/14/2019. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: -Consult facility bio-med or power inverter manual/manufacturer to ensure only pure sine wave inverters are being used in mobile/field EMS situations to charge the 9602 clipper, as emphasized in the new product caution. -Complete and return the Customer Acknowledgement Form to show your understanding of and compliance with this Field Safety Action via Email to: 3Mhealthcare@montage72.com. If you have questions regarding this matter, please contact your local 3M sales rep or the 3M Health Care Customer Helpline at 1-800-228-3957, option #6, Monday through Friday, 7:30 a.m. 6:00 p.m. Central Time.
FUTURO (TM) SPORT, QUICK STRAP ANKLE SUPPORT, REF 47736GEN, UPC 0 51131 19692 6
3M discovered that the Futuro" Quick Strap Ankle Brace (Cat. #47736EN) and ACE" Brand Deluxe Ankle brace (Cat. #207736) do not have the correct labeling. The products contain natural latex rubber, but do not include the appropriate caution statement.
The firm initiated their recall by letter on 01/30/2018. The letter stated the following: "Actions required: 1. Immediately discontinue sale of Futuro" Quick Strap Ankle Brace. 2. Isolate or quarantine any stock of the Futuro" Quick Strap Ankle Brace. 3. Call 1-866-746-2524, option #2, Monday to Friday, 8:00 am 4:30 pm Central time, to arrange for the return of the Futuro" Quick Strap Ankle Brace, Cat# 47736EN. 4. If you have further distributed the Futuro" Quick Strap Ankle Brace, please notify any of your customers at once. Please include a copy of this letter in your communications. We apologize for any inconvenience this may cause you. Should you have any questions regarding the product and return process, please feel free to contact 3M Customer Service at 1-866-746-2524, option 2, Monday to Friday, 8:00 am 4:30 pm Central Time."
3M Bair Hugger(TM) Normothermia System, Temperature Monitoring System Sensors Model 360 (Part Number 36000)
During a recent investigation, 3M confirmed that a programming translation error could occur in a small amount of the sensors that could lead to a temperature readout that is lower than the patients actual temperature.
The firm initiated their recall on 10/17/2017 via mail. International subsidiaries were notified via email, also on October 17, 2017.Distributors were asked to notify their customers and all direct consignees were directed to dispose of the product on site.
3M Bair Hugger(M) Normothermia System, Full Access Underbody Warming Blanket, REF 63500 The 3M Bair Hugger Temperature Management System is intended to prevent and treat hypothermia. In addition, the temperature management system can be used to provide patient thermal comfort when conditions exist that may cause patients to become too warm or too cold. The temperature management system can be used with adult and pediatric patients.
Adesign change to 3M(TM) Bair Hugger(TM) Full Access Underbody Warming Blanket, Models 63500 and 63700, can make these blankets more susceptible to unintended occlusion of airflow resulting in limited or partial inflation during use.
The firm, 3M, sent an "URGENT MEDICAL DEVICE RECALL" letter dated 1/19/2018 to its customers on 01/23/2018. The end user letter requested the following: "Actions Required: 1) Please immediately identify the affected product listed above, remove from your inventory and DO NOT USE. 2) Follow the instructions on the attached Customer Product Recall Acknowledgement Form, complete the form and return it to 3M via email at 3Mhealthcare@montage72.com. 3) Please dispose of all affected product per your institutional protocol and document disposal in the recall acknowledgment form." The distributor letter requested the following: "Actions Required: 1. Immediately discontinue distribution of the 3M(TM) Bair Hugger(TM) Full Access Underbody Warming Blanket, Models 63500 and 63700, with the referenced lot numbers above. 2. Determine if any stock of the 3M" Bair Hugger" Full Access Underbody Warming Blanket, Models 63500 and 63700, with the referenced lot numbers above remains in your inventory. 3. Complete the attached Distributor Product Recall Acknowledgement Form and return to 3M via email at 3Mhealthcare@montage72.com. It is important to notify 3M whether or not your facility has any inventory of this product. 4. Notify any of your customers who may have received the lots. Please use the attached customer notice and form provided in your communications to the customer. Customers should complete and return the enclosed form to 3M per the instructions on the form. Customers should not use the affected product and dispose per institutional protocol. 5. Dispose of any affected product in your inventory and document disposal in the recall acknowledgment form." If you have questions regarding this matter, please contact the 3M Health Care Customer Helpline at 1-800-228-3957, option #6, Monday through Friday, 7:30 a.m. 6:00 p.m. Central Daylight Time.
ACE(TM) BRAND, ULTRA LITE ANKLE brace: (a) Size Selection Medium, Cat #901014, UPC 051131019984 2; (b) Size Selection Large, Cat #901015, UPC 0 51131019985 9
Mold was found on the non-patient contact surfaces of the product and was identified as Aspergillus candidus.
The firm initiated their recall on 11/01/2017 by letter. The letter requested the consignee cease distribution of the recalled product, isolate it pending return. Distributors were asked to notify their customers including a copy of the 3M recall notice.
3M Fast Release Varnish, 5% Sodium Fluoride, Mint Flavor, Rx Only, single use. 200 pack, with each package containing 1 0.40 ml varnish and 1 applicator brush. Product is applied to tooth surfaces for sealing dentinal tubules and treatment of hypersensitive teeth.
Product has an unpleasant flavor due to a manufacturing process error resulting in an extraneous material being introduced into the product.
On or about 07/06/2018, 3M Health Care notified consignees via phone call or "URGENT Medical Device Recall" letter. Distributors were instructed to examine inventory for affected product, complete and return the Distributor Inventory Checklist to 3M Oral Care, return any affected product on hand, and provide the attached Dentist Letter and Dentist Inventory Checklist to any dentists that may have received the affected product. Dentists were instructed to examine inventory for affected product, complete and return the Dentist Inventory Checklist to 3M Oral Care, and return any affected product on hand. If you have any questions, please contact Regulatory Affairs Manager by telephone at 651-575-8052.
3M Ranger(TM) Pressure Infusor, Model 145, SKU 70200792979 The 3M Ranger Pressure Infusor is a hardware device intended to provide pressure to I.V. solution bags when rapid infusion of liquids is required.
It was discovered that one Ranger Pressure lnfusor Model 145, SN: 100873, produced a left chamber pressure that was slightly below the manufacturing specification.
The firm, 3M, sent a letter dated 5/22/2017, to its consignee/customer. The letter described the product, problem and actions to be taken. The consignee was informed that there is no safety issue; however, the firm will be replacing unit. In addition, a representative from 3M will be visiting the facility and exchanging the product for a new one. Please feel free to call (713) 292-4430 or email baprestera@mmm.com if you have any questions.
3M Universal Electrosurgical Pad, REF 9130 (100 pads / case) and 3M Universal Electrosurgical Pad with Cord, REF 9135-LP (40 pads / case) Product Usage: 3M Universal Electrosurgical Pads are designed to work with most electrosurgical unite (ESU) for virtually every surgical application where electrosurgery is utilized to provide a safe return path for electrosurgical current. Solid Universal Electrosurgical Pads are for use with generators that do not have a Contact Quality Monitoring System
3M is recalling Universal Electrosurgical Pads because a report of an unintended material (process liner) in the product. This may prevent or impede the safe return of electrosurgical current following Electrosurgical Unit (ESU) activation. This defect has the potential to increase the risk of a patient burn directly under the pad or at an alternate site of the body.
3M sent an Urgent Medical Device Recall letter dated October 26, 2016 to affected customers. The letter identified the affected product, problem, and actions to be taken. Customers were instructed to complete and return the attached Customer Product Return and Recall Form. Customers with questions can contact 3M Health Care Customer Helpline at 1-800-228-3957, 8:30 am - 7:00 pm EST.
3M Steri-Vac Gas Sterilizer/Aerator, models 5XL and 8XL.
3M discovered a valve with incorrectly labeled "input" and "output" orientation. This defect can result in the valve being installed backwards, creating a remote possibility of valve failure. A failure may result in EO being vented outside the sealed chamber during a limited period in the EO injection phase of the cycle.
3M sent an Urgent Medical Device Field Correction letter to customers beginning 01/22/2016. The letter identified affected product, and stated that a 3M Service representative will contact the consignee to inspect the sterilizer. Questions can be directed to 3M Health Care Service Line at 1-800-228-3957.
3M Coban Self-Adherent Wrap Shipper carton label identified the product as 3M Coban LF Latex Free Catalog #2081, lot number 2018-10AM.
Product mislabeled as latex free. Actual Catalog number 1581, lot 2020-10AN. contains latex. This could pose a health risk to users with sensitivity or allergic reaction to latex, which could range from mild to severe.
Consignees were sent via certified mail on 12/1/2015 a 3M letter dated November 25, 2015 and an emal on 12/5/2015 for the updated 3M "Urgent Medical Device" letter dated November 25, 2015. The letter was addressed to 3M Health Care Distributor. The letter described the problem, device involved in the recall and the action required. Advised consignees to quarantine the product, notify their customers and to complete and return the "Product Recall Form". Distributors were also provided with a "Customer" letter for distribution. For questions contact 3M Customer Helpline 1-800-228-3957.