—#36446

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

FDA product code: FRN — Pump, Infusion
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K880733
Affected lot / code info: 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

Why it was recalled

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

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Baxter Healthcare Corp. Rt.
Address: 120 & Wilson Rd, Round Lake, Illinois 60073

Distribution

Distribution pattern: Nationwide and internationally to Canada, Switzerland, Saudi Arabia and Kyrgyzstan

Timeline

Recall initiated: 2004-12-20
Posted by FDA: 2005-01-28
Terminated: 2006-05-11
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #36446. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.