Anesthesia Set, product code 2C9216; a sterile fluid path consisting of a 72'' long PVC with DEHP tubing with a green st
FDA device recall Z-0443-05 · posted 2005-01-28 · Terminated
Recall details
- Recalling firm
- Baxter Healthcare Corp.
- Reason for recall
- The anesthesia set was incorrectly labeled as an anti-siphon set, but the set does not contain an anti-siphon component.
- Action taken
- 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
- Status
- Terminated
- Product code
- FRN
- Quantity affected
- 485,197 sets
- Distribution
- Nationwide and internationally to Canada, Switzerland, Saudi Arabia and Kyrgyzstan
- Date initiated
- 2004-12-20
- Date posted
- 2005-01-28
- Date terminated
- 2006-05-11
- Location
- Round Lake, IL
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BARD PCA II INFUSION PUMP (K880733) | C.R. Bard, Inc. | 1988-06-20 |