FDA Medical Device Recalls (openFDA)
Baxter Healthcare Corp.: Baxter Spinal Anesthesia Trays; sterile, single use only procedure trays that contain BD 25G x 8.9 cm (3-1/2'') Whitacre Spinal Needles; Assembled by Baxter Healthcare Corporation, Deerfield, IL 60015
- Recall number
- Z-0800-05
- Recalling firm
- Baxter Healthcare Corp.
- Product
- Baxter Spinal Anesthesia Trays; sterile, single use only procedure trays that contain BD 25G x 8.9 cm (3-1/2'') Whitacre Spinal Needles; Assembled by Baxter Healthcare Corporation, Deerfield, IL 60015
- Status
- Terminated
- Initiated
- 2005-03-28
- Posted
- 2005-05-06
- Terminated
- 2008-03-04
- Reason
- The anesthesia trays contain BD 25G Spinal Needles which which have leakage at the plastic hub of the needle.
- Root cause
- Other
- Action
- Urgent Device Correction letters dated 3/28/05 were sent to the direct accounts via first class mail. The accounts were informed of the leakage associated with the plastic hub of the spinal needle contained in the trays, and were provided with a listing of product codes and lots numbers of the spinal trays affected. The accounts were instructed to check their inventory for the affected trays and to contact BD at 1-888-237-2762 for instructions on how to obtain replacement spinal needles. Replacement needles will be shipped overnight, and the accounts were instructed to remove and destroy the needle in the tray and replace it with the replacement needles when the tray is opened prior to the procedure.
- Quantity
- 127,340 trays
- Distribution
- Nationwide, Puerto Rico, Amaerical Samoa, Guam, Canada and Venezuela
- Lot, serial or model codes
- product code 1T2156, lots GD809251, GD809582; product code 1T2352, lot GD810325; product code 1T2356, lots GD809152, GD810333; product code 1T2450, lot GD809590; product code 1T2451, lot GD801282; product code 1T2456, lots GD810564, GD808519, GD800516, GD804492, GD805960, GD812024, GD810861, GD806323, GD810366, GD806620; product code 1T7457, lots GD810911, GD809624; product code 2T0086, lot 809335; product code 2T0188, lot GD812255; product code 2T0298, lot GD809632; product code 2T0310, lot GD809640; product code 2T0329, lot GD809657; product code 2T0341, lot GD808642; product code 2T0378, lot GD809673; product code 2T0455, lots GD810614, GD809699; product code 2T0458, lot GD811448; product code 2T0555, lots GD810622, GD809400; product code 2T0618, lot GD811182; product code 2T0642, lots GD810655, GD808931; product code 2T0643, lot GD811455; product code 2T0661, lots GD808956, GD809434; product code 2T0770, lot GD810275; product code 2T0783, lot GD810101; product code 2T0784, lot GD809830; product code 2T2001, lot GD810788; product code 2T2007, lots GD810416, GD812156; product code 2T2008, lot GD809467; product code 2T2011, lot GD811737; product code 2T2014, lots GD809475, GD811026; product code 2T2022, lot GD808683; product code 2T2023, lot GD808311; product code 2T2025, lots GD811471, GD810127; product code 2T2108,lot GD809004; product code 2T2226, lot GD810721; product code 2T2230, lots GD811059, GD808360; product code 2T2287, lot GD809491; product code 2T2342, lots GD811117, GD808410
- 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