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
FDA Recall Z-0443-05 · Posted 2005-01-28
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Recalling FirmBaxter Healthcare Corp.
Recall StatusTerminated
Product CodeFRN
Date Initiated2004-12-20
Date Terminated2006-05-11
Product Quantity485,197 sets
Reason for Recall
The anesthesia set was incorrectly labeled as an anti-siphon set, but the set does not contain an anti-siphon component.
Firm 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.
Root Cause
Other
Distribution Pattern
Nationwide and internationally to Canada, Switzerland, Saudi Arabia and Kyrgyzstan
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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