Recall Z-0861-2020 ยท GAA Needle, Aspiration And Injection, Disposable
Vitreq Bv
VitreQ 27G Blunt Needles with luer-lock connector-REF: CN27.D05 GTIN:8719214221669
| Date | Dec 17, 2019 |
| Status | Terminated |
| Reason | Microscopic tears of the sterile pouch may compromise sterility |
| Root cause | Package design/selection |
| Action | VitreQ issued Urgent Medical Device recall dated 12/16/19 letter states reason for recall, health risk and action to take: 1.Immediately examine your inventory and quarantine product from all lots subject to recall. If you have further distributed this product, please identify your customers and notify them at once of this product recall. Consider all potential users of this product in your user supply chain. You may provide a copy of this recall notification letter; 2.Complete the Attachment 1: Response Form enclosed IMMEDIATELY, as evidence of the product being returned, and we will credit y |
| Distribution | Nationwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.