Recall Z-0109-2014 ยท FPA Set, Administration, Intravascular
Baxter Healthcare Corp.
Vented Spike Adapter Product Code 2C0471, Sterile, nopyrogenic. Manufactured by an affiliate of Baxter Healthcare Corporation, Clintec Nutrition Division, Deerfield IL 60015 USA. An IV transfer device, used to transfer fluids in pharmacy compounding system.
| Date | Oct 30, 2013 (initiated Aug 30, 2013) |
| Status | Terminated |
| Reason | Potential tears in the pouch of six lots of Vented Spike Adapter Product Code 2C0471 |
| Root cause | Packaging |
| Action | The firm, Baxter, sent an "Urgent Product Recall" letter dated September 10, 2013 to its consignees/customers. The letter described the product, problem and actions to be taken. The customers were instructed to locate and remove all affected product from your facility; If you distributed the products to other facilities or departments, forward them a copy of the letter; complete and return the attached Customer Reply Form via fax to 1-224-270-5457 or scan and email to fca@baxter.com; and contact Baxter Healthcare Center for Service at 1-888-229-0001 between hours of 7:00 am and 6:00pm Central |
| Quantity | 49,344 units |
| Distribution | Nationwide distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.