Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall PROTEXIS Latex Micro Surgical Gloves Size 7.5

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall PROTEXIS Latex Micro Surgical Gloves Size 7.5 see related information
Date Initiated by Firm July 29, 2020
Date Posted August 28, 2020
Recall Status1 Open3, Classified
Recall Number Z-2916-2020
Recall Event ID 86131
510(K)Number K001924  
Product Classification Surgeon's gloves - Product Code KGO
Product PROTEXIS Latex Micro Surgical Gloves Size 7.5 - 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.
Code Information Item Code: 2D72NT75X Lot #: TS19060031, TS19060065, TS19060168, TS19060302, TS19080080, TS19080176, TS19080203, TS19080262, TS19090027, TS19090064, TS19090167, TS19090272, TS19100111, TS19100197, TS19100244, TS19100262, TS19110041, TS19110102, TS19110176, TS19110238, TS19120002, TS19120044, TS19120274, TS20020286, TS20030288, TS20040030, TS20040086, TS20050114  Additional Affected Lots as of 10/20/20: TS20040051, TS20040075, TS20040058, TS20040176, TS20040280, TS20040281, TS20040291, TS20050010, TS20050174, TS20050306, TS20050353, TS20060032, TS20060038, TS20060120, TS20060174, TS20060175, TS20060260, TS20050250
Recalling Firm/
Manufacturer		 Cardinal Health 200, LLC
3651 Birchwood Dr
Waukegan IL 60085-8337
For Additional Information Contact Customer Service
847-689-9101
Manufacturer Reason
for Recall		 A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs.
FDA Determined
Cause 2		 Under Investigation by firm
Action 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: "
Quantity in Commerce 7119625 total
Distribution US Nationwide distribution
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = KGO and Original Applicant = ALLEGIANCE HEALTHCARE CORP.
-
-