—#182772

Product

PROTEXIS Latex Micro Surgical Gloves Size 6.5 - Product Usage: This surgeon s glove is a disposable device made of natural rubber latex or synthetic rubber intended to be worn by operating room personnel to be a barrier protection from contamination. Various thickness for sensitivity or durability depending on need.

FDA product code: KGO — Surgeon'S Gloves
Device class: Class 1
Medical specialty: General, Plastic Surgery
510(k) numbers: K001924
Affected lot / code info: Item Code: 2D72NT65X Lot #: TS19060064, TS19060158, TS19060303, TS19060393, TS19070019, TS19070068, TS19070138, TS19070185, TS19070297, TS19080022, TS19080051, TS19080128, TS19080134, TS19080239, TS19080326, TS19090058, TS19090104, TS19090212, TS19090295, TS19100043, TS19100138, TS19100173, TS19100310, TS19110023, TS19110083, TS19110150, TS19110211, TS19110349, TS20020024, TS20020262, TS20030066, TS20030179, TS20030219, TS20030318, TS20040116 Additional Affected Lots as of 10/20/20: TS20040111, TS20040069, TS20040104, TS20040174, TS20040293, TS20050140, TS20050181, TS20050182, TS20050268, TS20050269, TS20050336, TS20050344, TS20050378, TS20060010,TS20060064, TS20060065, TS20060138, TS20060140, TS20060224, TS20060225, TS20060285, TS20060286, TS20070003, TS20070081 Additional Affected Lots as of 2/23/21: TS20070179

Why it was recalled

A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

Cardinal Health distributed an urgent medical device recall letter dated July 29, 2020 to customers. This letter instructs customers to quarantine all effected product and return the response form to the firm. Product should be returned through the location from which it was purchased. An URGENT MEDICAL DEVICE RECALL EXPANSION dated 10/16/20 was sent to customers. The purpose of this notification is to notify that we are expanding the previous action to include additional production lots. Please see Attachment 1 for all affected product codes and lots (new lots in italics). The new product lots were distributed between April 2020 and September 2020. Actions requested on your part: 1) CHECK all storage and usage locations to confirm whether you have any units of the affected product codes and lot numbers listed in Attachment 1. Locations of codes are shown in Attachment 2. 2) SEGREGATE and QUARANTINE all impacted on-hand product. 3) RETURN the enclosed acknowledgment form via facsimile (847-689-9101 or 614-652-9648) or email (GMB-FieldCorrectiveAction@cardinalhealth.com) and indicate the product code, lot and quantity of product youve quarantined or discarded. Please respond regardless of whether or not you have affected product. 4) NOTIFY any customers to whom you may have distributed, or forwarded product affected by this recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter. 5) CONTACT the appropriate Customer Service group to arrange for return and credit/replacement of any affected product Monday Friday between 8:00am - 5:00pm EST: " Hospital800-964-5227 " Federal Government800-444-1166 " Distributor800-635-6021 " All other Customers888-444-5440 6) CUSTOMERS that did not receive product directly from Cardinal Health should return product through the location where they purchased it. Please contact the Customer Service group for any questions related to this action: "

Recalling firm

Firm: Cardinal Health 200, LLC
Address: 3651 Birchwood Dr, Waukegan, Illinois 60085-8337

Distribution

Distribution pattern: US Nationwide distribution

Timeline

Recall initiated: 2020-07-29
Posted by FDA: 2020-08-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #182772. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.