Recall Z-2144-2010 ยท KPE Container, I.V.
Baxa Corporation
Halobag EVA Dual-Chamber Bag, Sterile R, 3000 mL Total Volume W/500 mL upper chamber, Order No. REF: 341, Baxa Corporation.
| Date | Aug 2, 2010 (initiated May 26, 2010) |
| Status | Terminated |
| Reason | Fill port cap on TPN bags may become detached prior to use, thus compromising the sterility of the fluid pathway. |
| Root cause | Process design |
| Action | Consignees were notified by e-mail and Baxa Bag Product Notice letter on 05/26/2010 with instructions to not use any bags if the fill port cap is detached. Photos of a detached cap and properly attached cap were included. Defective bags could be returned to Baxa for credit. Information available at 800-678-2292. |
| Quantity | 67,800 bags |
| Distribution | Worldwide distribution, including USA, Argentina, Australia, Bermuda, Brazil, Canada, China, Colombia, Hong Kong, Malaysia, Mexico, New Zealand, Pakistan, Panama, South Korea, Taiwan, United Kingdom, and Uruguay. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K900585 | TUBING SETS FOR BAXA EXACTA-MED PHARMACY PUMP Baxa Corp., Sub. of Cook Group, Inc., Apr 18, 1990 |