Recall Z-0370-2022 ยท FYA Gown, Surgical
Cardinal Health
SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-X-Large SKU: 9041
| Date | Nov 2, 2021 |
| Status | Open, Classified |
| Reason | Potential for open packaging seals compromising the sterility of the surgical gowns |
| Root cause | Process control |
| Action | Cardinal Health issued Urgent Medical Device Recall Letter dated November 2, 2021, stating reason for recall, health risk and action to take: 1) REVIEW your inventory for affected product. 2) SEGREGATE and QUARANTINE all on-hand product that is confirmed to be labeled per Attachment 1. 3) NOTIFY any customers to whom you may have distributed or forwarded affected product about this product action. 4) RETURN the enclosed acknowledgment form via fax to 614-652-9648 or email to gmb-fieldcorrectiveaction@cardinalhealth.com, whether or not you have affected product. 5) CONTACT the appropriate Custo |
| Quantity | 231,219 units |
| Distribution | Worldwide distribution - US Nationwide and the countries of Chile, Thailand, Canada, Israel, LATAM Dist.Qatar, LATAM/Panama, LATAM/Mexico, LATAM/Colombia, LATAM/Costa Rica. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K023167 | BREATHABLE SURGICAL GOWN Allegiance Healthcare Corp., Oct 2, 2002 |