Recall Z-2913-2020 ยท KGO Surgeon'S Gloves
Cardinal Health 200, LLC
PROTEXIS Latex Micro Surgical Gloves Size 6.0 - 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.
| Date | Aug 28, 2020 (initiated Jul 29, 2020) |
| Status | Completed |
| Reason | A degradation defect was found that could lead to holes and donning tears at the folding area around the cuffs. |
| Root cause | 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 l |
| Quantity | 7119625 total |
| Distribution | US Nationwide distribution |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K001924 | COATED STERILE LATEX POWDEER-FREE SURGICAL GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAM OR LESS0 Allegiance Healthcare Corp., Jul 14, 2000 |