Recall Z-0902-2022 ยท KGO Surgeon'S Gloves
Cardinal Health 200, LLC
Cardinal Health PROTEXIS PI and PI Classic, Surgical Gloves
| Date | Mar 15, 2022 |
| Status | Completed |
| Reason | Product was distributed without being sterilized. |
| Root cause | Under Investigation by firm |
| Action | A recall letter dated 03/16/2022 was distributed to impacted consignees. The letter informs consignees that a portion of the distributed lots were distributed without undergoing sterilization. Customers should review their inventory for the impacted lots, segregate and quarantine all affected product, complete the acknowledgement form and return to Cardinal Health. Any customers who may have received further distributed product should be contacted and provided the recall information. |
| Quantity | 486,578 pairs |
| Distribution | Product distributed throughout United States and Guam |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K110272 | STERILE POLYISOPRENE POWDER-FREE SURGICAL GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUG Cardinal Health, Inc., Jun 8, 2011 |