Recall Z-1620-2014 ยท FMF Syringe, Piston
Baxter Corporation Englewood
RAPIDFILL Syringe Strip, For use with RAPIDFILL Automated Syringe Filler (ASF): H93890200 RAPIDFILL Syringe Strip, White. H93890221 RAPIDFILL Syringe Strip, Yellow. H93890222 RAPIDFILL Syringe Strip, Orange. H93890223 RAPIDFILL Syringe Strip, Red. H93890225 RAPIDFILL Syringe Strip, Blue. H93890227 RAPIDFILL Syringe Strip, Salmon. H93890229 RAPIDFILL Syringe Strip, Violet. H93890231 RAPIDFILL Syrin
| Date | May 14, 2014 (initiated Apr 16, 2014) |
| Status | Terminated |
| Reason | Possible breach in sterile barrier for inner and outer bags of the product. |
| Root cause | Process control |
| Action | Baxter sent an Urgent Product Recall letter dated April 30, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Baxter is requesting that you take the following actions: 1. Locate and remove all affected product from your facility (the product code and lot number can be found on the individual product package or shipping carton). 2. To return the affected product, receive credit and order replacement, please contact Baxter Healthcare Center for Service at 1-888-229-0001, Monday through Friday, b |
| Quantity | 774, 600 |
| Distribution | Worldwide Distribution - US Distribution including the states of AL, AZ, CT, CA, FL, GA, OH, OR, IL, KS, MA, MI, MN, MO, NC, PA, HI, TN, VA, NV and WI and the country of Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.