Recall Z-2520-2021 ยท GAA Needle, Aspiration And Injection, Disposable
North American Rescue LLC.
10 ga ARS Decompression Needle, Part Number ZZ-0298
| Date | Aug 27, 2021 |
| Status | Terminated |
| Reason | The device includes the incorrect Instructions for Use. |
| Root cause | Under Investigation by firm |
| Action | Consignees will be notified by 09/01/2021 via email with read/delivery receipt followed by First Class Mail letter. Additionally, the recall notification will be posted to the firm's website, www.marescue.com. Consignees are asked to do the following: 1. Examine your inventory and quarantine all product identified in this recall notification. 2. Discontinue all distribution or use of the recalled products identified in this recall notification. 3. Identify the ZZ-0298, with the aid of ENCLOSURE 1, and verify the recalled lot W668NI, W693WF, W694ZH, W695DD, W696FN, or W697IJ. UDI number 00842 |
| Quantity | 51,424 units |
| Distribution | Distribution throughout US and Puerto Rico OUS consignees in Australia, Czech Republic, Denmark, France, Germany, Ireland, Italy, Poland, and Switzerland |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.