Recall Z-1558-2021 ยท OFM Phlebotomy Blood Collection Kit
Medical Action Industries, Inc. 306
Kit: Blood Culture. MAI Kit Part Number: 80315D
| Date | May 12, 2021 (initiated Apr 9, 2021) |
| Status | Terminated |
| Reason | Medical convenience kits are being recalled due to a potential breach in the package integrity of a component, the BD ChloraPrep 3mL applicator. |
| Root cause | Package design/selection |
| Action | A written notification letter titled, "URGENT: RECALL NOTIFICATION" was sent to all consignees on 04/09/2021 via email. The letter sent to the distributors instructs the consignees to immediately examine all inventory locations and discontinue use of Medical Action trays affected by this recall. The consignees are instructed to discard any inventory they may have on hand in accordance with the distributor's facility s standard procedures. If any of the affected products identified above were further distributed, the distributor is to ensure all end-users are appropriately notified of this p |
| Quantity | 205 cases (20 kits per case) |
| Distribution | Distributed US nationwide to OH, OR, FL and CA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.