Devicor Medical Products Inc Recalls
Showing 1-4 of 4 recalls
HydroMARK Breast Biopsy Marker, Model No. 4010-05-08-T4
Small patient labels do not match the primary device label. The primary device label accurately identifies the product as 4010-05-08-T4, while the smaller patient label incorrectly identifies the product as 4010-05-08-T3.
On March 30, 2022, the firm distributed Urgent Medical Device Recall letters to their customers via email. Customers were informed of the labeling issue. Users were instructed to examine their inventory and identify any affected product. Users should contact their local sales representative for correction of any affected devices. The sales representative will be on site to remove the affected patient labels. Please do not use affected patient labels from this lot. If you have any additional questions, comments or concerns please contact the firm's Customer Support at +1 877-926-2666. You may also email mmtchnrecall@mammotome.com.
Neoprobe GDS Control Unit, Model Number NPCU3
It was discovered during a documentation review that China has the software version as v5.01 approved for use in China. The current software version on devices distributed in China since 2011 is v6.01.
URGENT FIELD CORRECTION notification letters were sent to customers. Action to be taken by the user: As a result of this notification, please conduct the following: " Please Examine your inventory, identify and reference attached product list to determine if you have an affected device. " If you have any Devices referenced, immediately contact Minghui Qian at +86 21 8031 6329 " If in use on a patient, continue to use the device if an alternative device is not available. " Please complete and return the enclosed Response Form of Acknowledgement. " If you have any additional questions, comments or concerns please contact our Customer Support at +86 21 8031 6329. You may also email mmtchnrecall@mammotome.com.
Mammotome Revolve Dual Vacuum Assist Biopsy System Model number: MST1009 & MST0815. Each disposable probe is packaged within a thermoformed tray and covered with a pre-printed (product code and graphics) Tyvek lid. Each tray is labeled on-demand after sealing with a lot number and expiration date. Trays are kitted into sets of five probes and packaged within a sales carton. Two sales cartons are then packed into a corrugated case and shipped to the global distribution center. Device is labeled
A 10 Gauge needle, 9cm long was shipped in an 8 Gauge needle, 15 cm package.
An Urgent: Medical Device Recall of Mammotome Revolve Dual Vacuum Assist Biopsy Probe due to Potential Product Code Mislabel communication was sent to the customers via 1st class USPS on June 6, 2016. The labeling and the Customer response form was also attached. Customers were asked to examine their inventory and quarantine the affected product. If the product was further distributed, those customers are to be identified and notified. The letter stated that the assigned sales rep would be in contact to support the identification, inspection and replacement of the recalled products. Customers are to complete and return the enclosed response form. Questions are to be directed to Mammatome Customer Service 1-877-926-2666.
Mammotome Revolve Dual Vacuum Assist Biopsy System The device is used to sample breast tissue that has been identified as suspicious under imaging guidance
The device did not have Revolve Stereo Probe labeling, no product code indicating the size and length of the probe, no sterilization sticker or lot number.
Devicor sent an Urgent Medical Device Recall letter dated March 10, 2017 to all affected consignees via first class mail. The recall response rate will be tracked and reconciled by consignee's response form, certifications of product inventory, and/or disposal. Consignees were asked to complete and return the enclosed response form as soon as possible. Consignees with any questions were instructed to call Mammotome Customer Service at 1-877-926-2666. For questions regarding this recall call 513-864-9158.