FDA Recall Terminated

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

Recall: Z-0443-05 · Initiated December 20, 2004

Recall

Recall Number: Z-0443-05
Event Number: 30715
Firm: Baxter Healthcare Corp. Rt.
FEI Number: 1416980
Product Code: FRN
Status: Terminated
Root Cause: Other
Initiated: December 20, 2004
Posted: January 28, 2005
Terminated: May 11, 2006
Address: 120 & Wilson Rd, Round Lake, IL, 60073

Description

Reason

The anesthesia set was incorrectly labeled as an anti-siphon set, but the set does not contain an anti-siphon component.

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 concerning the return process were directed to NCC at 1-800-300-5085. Any medical or technical questions were directed to Baxter at 1-800-422-9837. Wholesalers were requested to conduct sub-recalls from their sub-accounts.

Distribution

Nationwide and internationally to Canada, Switzerland, Saudi Arabia and Kyrgyzstan

Quantity

485,197 sets