Recall Z-0731-2016 ยท FMF Syringe, Piston
Baxter Corporation Englewood
Baxter, RAPIDFILL Syringe Strip, 10 ml. For use with RAPIDFILL Automated Syringe Filler (ASF)
| Date | Jan 30, 2016 (initiated Dec 21, 2015) |
| Status | Terminated |
| Reason | All lots of RAPIDFILL Syringe Strips lack evidence supporting the packaging claim for 12-month shelf life on released product. |
| Root cause | Packaging process control |
| Action | An Urgent Product Recall notification was sent to consignees via USPS, first class mail on 12/21/15. Baxter Healthcare has asked customers to do the following: l. Locate and remove all affected product from your facility. The product code and lot number can be found on the individual product or shipping carton. 2. Contact Baxter Healthcare Center for Service to arrange for return, credit and alternative products. 3. Complete the attached customer reply form and return it to Baxter by either fax or scanned e-mail. 4. Communicate the contents of the letter to your staff if affected products are |
| Quantity | 4,695 |
| Distribution | Worldwide Distribution-US (nationwide) and the countries of Canada, Sweden, Germany, and the Netherlands. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K980181 | TERUMO DISPOSABLE HYPODERMC SYRINGE Terumo Medical Corp., Apr 2, 1998 |