Recall Z-2708-2011 ยท FPA Set, Administration, Intravascular
Baxter Healthcare Corp.
Baxter Solution Set for Epidural Use, 110" (2.8 m), Male Luer Lock Adapter; a sterile, single use, nonpyrogenic fluid pathway for use with 6200 and 6300 series Flo-Gard Volumetric Infusion Pumps; Baxter Healthcare corporation, Deerfield, IL; product code 2C7554s The tubing set is intended for use with Flo-Gard Infusion Pumps to provide epidural delivery of anesthetic or analgesic drugs for perio
| Date | Jun 29, 2011 (initiated May 31, 2011) |
| Status | Terminated |
| Reason | The lot of Baxter Solution Set for Epidural Use is being recalled because the position of the slide clamp and roller clamp may have been reversed during assembly. The reversed orientation of the slide clamp and roller clamp will cause the set to be incorrectly loaded into an infusion pump, resulting in fluid flow from the patient to the pump, rather than from the pump to the patient. |
| Root cause | Employee error |
| Action | Baxter Healthcare sent Urgent Product Recall letters dated May 31, 2011, via UPS overnight delivery to all affected customers. The letters identified the product, the problem, and the action to be taken by the customer. Customers were instructed to locate and remove all affected inventory from their facility and return it to Baxter after calling Baxter Healthcare Center for Service at 1-888-229-0001 to obtain the returned goods authorization The accounts were also requested to complete the attached customer reply form confirming their receipt of the letter and fax it to Baxter at the number |
| Quantity | 13,920 units |
| Distribution | Worldwide Distribution - USA including Alabama, Arizona, California, Illinois, Kentucky, Louisiana, New Mexico, North Carolina, Ohio, Oregon, Tennessee and Washington, and internationally to Canada and South Africa. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K925058 | BARD AMBU PUMP SPIK TUB SET PACRET PROVID PUMP SET C.R. Bard, Inc., Aug 3, 1993 |