FDA Medical Device Recalls (openFDA)
Becton Dickinson & Company: BD Vacutainer Push Button Blood collection Sets with Pre-Attached Holder;Catalog Number : 367352: 21G x 3/4" x 12"; 0.8 x 19mm x 305mm, Wingset PBBCS, BD Diagnostics, Franklin Lakes, NJ
- Recall number
- Z-0589-2008
- Recalling firm
- Becton Dickinson & Company
- Product
- BD Vacutainer Push Button Blood collection Sets with Pre-Attached Holder;Catalog Number : 367352: 21G x 3/4" x 12"; 0.8 x 19mm x 305mm, Wingset PBBCS, BD Diagnostics, Franklin Lakes, NJ
- Status
- Terminated
- Initiated
- 2007-11-20
- Posted
- 2008-01-23
- Terminated
- 2008-09-08
- Reason
- Safety Mechanism Failure: the safety mechanism of the BD Vacutainer Push Button Collection Set with Pre-attached holder cannot be activated; thus the needle cannot retract into the rear barrel.
- Root cause
- Material/Component Contamination
- Action
- BD sent Recall notification letters, Urgent Class II Product Recall, to customers and distributors on 12/10/07 through a third party, West Inc., Appleton, Wi. Mailings were sent return receipt requested. Letters requested immediate inventory search and product return. Contact number for questions was given as 1-800-631-0174
- Quantity
- 105,200 USA; 400 Canada
- Distribution
- Worldwide-USA and Canada
- Lot, serial or model codes
- Lot #'s : 7117874, 7157882, 7159943, 7180478, 7215299, 7215300, 7324340, and 7234341.
- 510(k) numbers
- ["K011984"]
- PMA numbers
- not on file
- Product code
- JKA
- Firm FEI
- 2243072
- Firm city
- Franklin Lakes
- Firm state
- NJ
- 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