FDA Medical Device Recalls (openFDA)
Baxter Healthcare Corp.: Baxter Epidural Anesthesia Trays that contain BD Catheter Connectors; Sterile, single use only kits containing an epidural needle, epidural catheter, glass LOR syringe and non-latex components for the preparation and insertion of the epidural needle and catheter; Assembled by Baxter Healthcare Corporation, Deerfield, IL U.S.A.
- Recall number
- Z-0509-06
- Recalling firm
- Baxter Healthcare Corp.
- Product
- Baxter Epidural Anesthesia Trays that contain BD Catheter Connectors; Sterile, single use only kits containing an epidural needle, epidural catheter, glass LOR syringe and non-latex components for the preparation and insertion of the epidural needle and catheter; Assembled by Baxter Healthcare Corporation, Deerfield, IL U.S.A.
- Status
- Terminated
- Initiated
- 2006-01-10
- Posted
- 2006-02-08
- Terminated
- 2008-03-17
- Reason
- The BD catheter connector contained in the Epidural Anesthesia Trays may not fully secure the catheter and allows the catheter to either become loose or disconnected from the connector.
- Root cause
- Other
- Action
- Baxter sent Urgent Product Recall letters dated 1/10/06 to their customers, to the attention of the Director of Anesthesia, via first class mail on the same date. The accounts were informed that the BD catheter connector in the tray may not fully secure the catheter, resulting in the possible leakage or incomplete delivery of medication. The accounts were instructed to examine their inventory for the affected lots of product, remove it from inventory and destroy it for credit. Any questions were directed to the Center for One Baxter at 1-800-422-9837.
- Quantity
- 2,200 trays
- Distribution
- Nationwide
- Lot, serial or model codes
- product code 2T0609, lot GD822585; product code 2T2263, lot GD822874; product code 2T2367, lots GD822551 and GD822981; product code 2T2386, lot GD822452
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- CAZ
- Firm FEI
- 1416980
- Firm city
- Round Lake
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28