Recall Z-2051-2021 ยท GCJ Laparoscope, General & Plastic Surgery
Baxter Healthcare Corporation
EASYGRIP FLO-41 US. For delivering hemostatic agents to bleeding sites through a trocar.
| Date | Jun 15, 2021 |
| Status | Terminated |
| Reason | There is a discrepancy in the expiry date encoded into the 2D barcode. The correct expiration date is the human-readable date |
| Root cause | Employee error |
| Action | On June 15th 2021, the firm sent a letter to its customers with the following instructions: 1. Healthcare providers may continue to safely use the EASYGRIP FLO-41 delivery system while following the human readable expiry date printed on the primary and secondary package labeling, which are also listed in the table above. 2. If you received this communication directly from Baxter, complete the enclosed Baxter customer reply form and return it to Baxter by e-mailing it to fca@baxter.com, even if you do not have any inventory. Returning the customer reply form promptly will confirm your receipt |
| Quantity | 4,752 units |
| Distribution | United States, Australia, Hong Kong, New Zealand, Belgium, Cyprus, Ireland, Italy, Netherlands, Norway, Portugal, Spain, Sweden, and United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K193137 | EASYGRIP FLO-41 Precision MIS Delivery System Baxter Healthcare Corportation, Jan 8, 2020 |