2020 Product Recalls

SMART Connect Mini Devices Recalled for Fire Hazard

The device's power supply can overheat while charging, and cause the plastic enclosure to fly off, posing fire and injury hazards.

Consumers should immediately stop using the recalled devices and should not unplug their installed devices until they are contacted by Anticimex to schedule a removal appointment and provide further instructions. The replacement and installation of the new device will be free of charge. Anticimex is directly contacting all known purchasers.

FSIS Issues Public Health Alert for Frozen, Fully Cooked, Not Shelf Stable Chicken Sriracha Ravioli Products Due to Misbranding and an Undeclared Allergen

Misbranding, Unreported Allergens

Biomet Comprehensive Reverse Shoulder Glenosphere Mini Baseplate with Taper Adapter-Shoulder Prosthesis item: 010000589 - Product Usage: intended to serve as the foundation for the reverse shoulder prosthesis head (glenosphere).

Product potentially being packaged without a taper adapter or baseplate. The package should contain one (1) baseplate and one (1) taper adapter, product may be packaged with two (2) baseplates and no (0) adapters or with no (0) baseplates and two (2) adapters

Zimmer Biomet issued Urgent Medical Device Recall Letter dated 9/02/20 to Distributors via email and Hospital Risk Mangers via courier stating reason for recall, health risk and action to take: 1. Review this notification and ensure that affected personnel are aware of the contents. 2. If you have unconsumed affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. Your Zimmer Biomet sales representative will remove the affected product from your facility. 3. Complete Attachment 1 Certificate of Acknowledgement and send to CorporateQuality.PostMarket@zimmerbiomet.com. This form must be returned even if you do not have affected products at your facility. 4. Retain a copy of the acknowledgement form with your recall records in the event of a compliance audit of your facilitys documentation. 5. If you have further questions or concerns after reviewing this notice, please call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday. Calls received outside of call center operating hours will receive a voicemail prompt or be transferred to an on-call representative in the event of an emergency. Alternatively, your questions may be emailed to CorporateQuality.PostMarket@zimmerbiomet.com.

Cat & Jack Infant-Toddler One-Piece Rashguard Swimsuits Recalled for Choking Hazard

The snaps can break or detach from the suits, posing choking and laceration hazards to children.

Consumers should immediately take the recalled one-piece Rashguard swimsuits away from children and return them to any Target Store for a full refund. Consumers that purchased the one-piece Rashguard swimsuit on Target.com can contact Target to receive a prepaid return label to return the swimsuit.

Sensorcaine-MPF (Bupivacaine HCl and Epinephrine Injection, USP), 0.5%, 150 mg per 30 mL (5 mg per mL), 30 mL Single Dose Vial (NDC 63323-462-01), packaged as 25 Single Dose Vials per tray (NDC 63323-462-37), Rx only, Fresenius Kabi, Lake Zurich, IL 60047.

Subpotent Drug: Low out-of-specification assay results for the epinephrine component.

Auryxia (ferric citrate) tablets, 210 mg, 200-count bottles, Rx only, Manufactured for and distributed by: KERYX BIOPHARMACEUTICALS, INC., One Marina Park Drive, 12th Floor, Boston, MA 02210, NDC 59922-631-01

CGMP Deviations

Vasopressin 20 Units added to 0.9% Sodium Chloride 100 mL Rx Only, Single Dose Container, SCA Pharmaceuticals 8821 Knoedl Ct. Little Rock, AR 72205 Bar Code 70004093232

Subpotent drug.

Hydroxyzine Hydrochloride Oral Solution, USP (Syrup), 10 mg/5 mL, packaged in a) 4 fl oz (118 mL) bottle, NDC 60432-150-04, b) 1 pint (473 mL), NDC 60432-150-16, Rx Only, Manufactured By: Morton Grove Pharmaceuticals, Inc., Morton Grove, IL 60053

Failed Impurities/Degradation Specification: OOS for the following - unknown degradant/impurity, 4-chorobenzophenone, and for total impurities.

CANYON BAKEHOUSE GLUTEN FREE BAGELS EVERYTHING NET WT. 14 OZ (396g) Canyon Bakehouse, LLC Johnstown, CO 80534 UPC 8 53584 00221 8

The firm discovered that some of their products showed higher than acceptable levels of gluten. They placed the product on hold for destruction however, one shipper sent products into commerce for distribution.

CACAO MARKET MARIE BELLE NEW YORK; Dark Chocolate Pearls; Ingredients: Cocoa bean, sugar, biscuit cereals (wheat flour, sugar, wheat malt, wheat starch, raising agent: E500ii, palm oil, salt, vanilla flavoring 17%, cocoa butter, emulsifier (soy lecithin), natural vanilla extract; This product may contain traces of nuts, egg protein, peanut and lupine; Net Weight. 5oz

Product contains undeclared milk.

Organic fresh cut basil packaged in plastic clamshell containers The Fresh Market Organic Basil NET WT 0.5oz (14g), UPC:7-37094-23027-2 Good & Gather organic basil NET WT 0.5oz (14.17g), UPC:0-85239-12215-0 Naturally Better Organic Fresh Cut Basil 0.5oz (14g), UPC:6-07880-20230-4 Naturally Better Organic Fresh Cut Basil 0.5oz (14g) UPC: 6-07880-20230-4 Naturally Better Organic Fresh Cut Basil 0.5oz (14g), UPC:6-07880-20230-4 Nature Promise Organic Basil NET WT 4 OZ (113g), UPC:6-88267-16

Possible contamination with Cyclospora

Organic Basil,15 bags, Net. Wt.15Lbs case.

Possible contamination with Cyclospora

Presidents Choice Coleslaw 14 oz. plastic bag UPC:0-6038322267-3

CCP deviation with the wash process

Provolini Antipasta Net Wt. 7 oz (198g) UPC 0-72368-39343-8

Product mis-packaging which lead to undeclared milk

Zimmer Pressure Sentinel Intramedullary Reaming System, Guide Wire, Bullet Tip, 2.4 mm Diameter Item Number: 00-2228-024-00 Product Usage: A single use surgical instrument used during orthopaedic surgery for implantation of a prosthesis.

Various Trauma Guide Wires- creases in the sealing area on the end opposite of the product's chevron opening compromising product sterility

Zimmer Biomet conducted recall to distributors and hospital risk managers on 10/22/18, distributors notified via email. Hospital risk managers, as well as distributors with product, will be notified via Fed'X." Distributors responsibilities include:- Locating and removing the product in their territory, as well as identifying hospitals with fielded inventory. Distributors will return on-hand product to Zimmer Biomet and ensure all of their products are accounted for using the form provided in the letter. Hospital risk managers will be provided with a letter identifying the issue and their responsibilities. These responsibilities include: Ensuring affected personnel are aware of the notice contents - Assisting the Zimmer Biomet sales representative with the quarantine of the affected products. Certificate of Acknowledgement complete and send to CorporateQuality.PostMarket@zimmerbiomet.com. This form must be returned even if you do not have affected products at your facility. Questions or concerns after reviewing this notice, please call customer service at 574-371-3071 between 8:00 am and 5:00pm EST, Monday through Friday

Roche cobas 8000 modular analyzer series (i.e., cobas 8000 ISE module; cobas c 502, 701, and 702 modules; and cobas e 602 and 801 modules). Chemistry Analyzer (photometric discrete), for clinical use Part Number: 08763662001

Potential for Changed Configuration Settings on the cobas 8000 modular analyzer series/cobas pro integrated solutions, may cause incorrect results in several affected parameters. In the case of poor sample quality, discrepant results may remain undetected due to the absence of associated data flags.

Roche recall issued Urgent Medical Device Correction (UMDC TP-01165 and UMDC TP-01169) notifications on 12/8/2020 via UPS Ground (receipt required). Both UMDCs will also be posted to the diagnostics.roche.com website. Letter states reason for recall, health risk and action to take: Consignee Instructions: Inform any operators who use the cobas 8000 modular analyzer series or the cobas pro integrated solutions of the potential hazards associated with this issue and provide a copy of the UMDC notification, as appropriate. Follow the actions outlined in the Customer Actions to Determine if the Issue Has Occurred section of the UMDC. Confirm that you have backed up your most recent settings. Repeat this maintenance function whenever a system setting is changed. Consult with the physician or pathologist at your facility to determine specific clinical implications for your patients. Complete the enclosed faxback form and return it following the instructions on the form. File this UMDC for future reference. Contact the Roche Support Network Customer Support Center, 24 hours a day, seven days a week at 1-800-428-2336 if you have questions about the information contained in this UMDC.

Contour VL Variable Length Ureteral Stent, UPN M0061801550, M0061801560, M0061801570

Trace amounts of metallic debris were found on the stent related to the manufacturing process. The debris was confirmed to be particles of nickel.

On November 16, 2020, the firm distributed Urgent Medical Device Removal letters to affected customers. Customers were informed of the product issue and asked to take the following actions: - Verify whether you have any product from the affected lots/batches within your inventory - Immediately cease use or distribution of any remaining unused product from the affected lots/batches - Segregate affected material and return it to BSC in accordance with removal instructions included in the letter. - Distributors should forward the notification to their customers Your local Sales Representative can answer any questions that you may have regarding this notification.

Fresenius Liberty Cycler Set Single Conn. Ext. DL. Part Number: 050-87216. Acute and chronic peritoneal dialysis.

There is a small risk of a leak in Cycler Sets and if the Cycler Set is punctured, the dialysate may become contaminated potentially resulting in peritonitis.

Fresenius Medical Care began contacting the affected customers by telephone and mailing an "URGENT: FMCNA LIBERTY CYCLER SET RECALL" letter and Return Receipt form dated October 31, 2012. The letters identified the specific part number and product lot and request that customers discontinue use of the lots immediately and to return unused product to FMCNA. Instructions are provided for returning the product, asking customers to isolate and discontinue use of the lot number 12BR08009 and place the product in a secure, segregated area. Consignees were instructed to contact their Fresenius Medical Care Customer Service Team at 1-800-323-5188 for instructions on how to return the recalled product.

AC Powered hospital adjustable bed.

Potential Hazard of Unsupervised Patient being out of Bed and/or Potential Patient Fall.

The firm sent a Medical Device Recall-User Manual letter dated May 4,2020 to customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to identify affected units. Units bearing the options numbers OL360011P or OL360017P and manufactured between January 26th, 2015 and January 24rd,2020 were packaged with a User Manual affected by this recall and subject to improvement with the attached addendum. A list of serial numbers traced as being in your facility is attached to this communication. The manufacturing date and serial number are located on the manufacturer label located at the head end of the device. Actions Needed: 1. Please carefully read the attached addendum and promptly disseminate its contents to all concerned personnel in your facility, including more importantly to all persons who are or may be called upon to use/operate the bed. 2. Locate the User Manual related to your FL36 bed and insert the addendum, for future reference, in the appropriate section of the instruction manual for the FL36 ook-snow, ook-snow MH or ook-cocoon beds. 3. If you have loaned or sold any of the beds listed in this letter, please, forward a copy of this notice to the new users and advise us of their new location. 4. If you have disposed of any of the affected beds and they are no longer in use, please, advise us of their obsolescence by providing us with their serial numbers. 5. Call at 1-844-409-4030 or at 1-418-247-3986, extension 4 to confirm that your facility received Umano Medical Inc.s addendum to the User Manual regarding the Zeroing Procedure and the Detection System applicable to the above-mentioned product(s) and that the Actions Needed have been taken and completed by your facility.

CANYON BAKEHOUSE GLUTEN MOUNTAIN WHITE BREAD NET WT. 18oz (1lb 2oz) 510g Canyon Bakehouse, LLC Johnstown, CO 80534 UPC 8 53584 00200 3

The firm discovered that some of their products showed higher than acceptable levels of gluten. They placed the product on hold for destruction however, one shipper sent products into commerce for distribution.