Recall Z-0443-05 ยท FRN Pump, Infusion
Baxter Healthcare Corp.
Anesthesia Set, product code 2C9216; a sterile fluid path consisting of a 72'' long PVC with DEHP tubing with a green stripe, inner diameter of 0.040'', priming volume 1.7 mL, with a luerlock connector with fixed collar; 60 sets per case
| Date | Jan 28, 2005 (initiated Dec 20, 2004) |
| Status | Terminated |
| Reason | The anesthesia set was incorrectly labeled as an anti-siphon set, but the set does not contain an anti-siphon component. |
| Root cause | Other |
| Action | Urgent Product Recall letters dated 12/20/04 were sent to the direct accounts on the same date via next day air. The accounts were informed that the sets were incorrectly labeled as anti-siphon sets and were requested to immediately discontinue use of the affected lot numbers of product code 2C9216 and return the sets to Baxter c/o NNC Group, 2670 Executive Dr., Indianapolis, IN 46241, following the enclosed instructions. A matrix containing key attributes of product code 2C9216 and two other product codes was provided for consideration of alternates to the recalled product. Any questions c |
| Quantity | 485,197 sets |
| Distribution | Nationwide and internationally to Canada, Switzerland, Saudi Arabia and Kyrgyzstan |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K880733 | BARD PCA II INFUSION PUMP C.R. Bard, Inc., Jun 20, 1988 |