Z-0443-05

Anesthesia Set, product code 2C9216; a sterile fluid path consisting of a 72'' long PVC with DEHP tubing with...

Name: Z-0443-05 Anesthesia Set, product code 2C9216; a sterile fluid path consisting of a 72'' long PVC with DEHP tubing with...
Creator: Baxter Healthcare Corp.
Published: 2004-12-20
License: https://open.fda.gov/license/

Baxter Healthcare Corporation / initiated 2004-12-20 / Terminated / root cause: labeling and UDI

FDA source

Baxter Healthcare Corp. began a recall of 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''... on 2004-12-20. The reason FDA records is "The anesthesia set was incorrectly labeled as an anti-siphon set, but the set does not contain an anti-siphon component". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0443-05
Status: Terminated
Initiated: 2004-12-20
Posted: 2005-01-28
Terminated: 2006-05-11
Recalling firm: Baxter Healthcare Corporation
Product: 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
Product code: FRN Pump, Infusion
Reason for recall: The anesthesia set was incorrectly labeled as an anti-siphon set, but the set does not contain an anti-siphon component.
Root cause tag: labeling and UDI
FDA 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 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.
Quantity in commerce: 485,197 sets
Distribution: Nationwide and internationally to Canada, Switzerland, Saudi Arabia and Kyrgyzstan
Product codes and lots: lots UR192765, UR192815, UR192856, UR194290, UR200097, UR200964, UR203109, UR204693, UR208017, UR208116, UR208371, UR209569, UR209791, UR213769, UR215699, UR217141, UR218172, UR218560, UR218669, UR218982, UR222679, UR224584, UR225227, UR227884, UR228353, UR229310, UR232892, UR233841, UR234443, UR234666, UR236554, UR236588, UR239087

Product code FRN

K880733Class IIBard Pca II Infusion PumpC.R. Bard, Inc. / cleared 1988-06-20

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)