FDA Medical Device Recalls (openFDA)
Becton Dickinson & Company: VACUTAINER Brand Push Button Blood Collection Sets.
- Recall number
- Z-0549-04
- Recalling firm
- Becton Dickinson & Company
- Product
- VACUTAINER Brand Push Button Blood Collection Sets.
- Status
- Terminated
- Initiated
- 2003-12-17
- Posted
- 2004-02-25
- Terminated
- 2004-03-15
- Reason
- A hole was noticed in the 'blister pack' that is used to package the device and provides the sterility barrier. Sterility could be compromised.
- Root cause
- Other
- Action
- BD Sales Organization directly contacted all customers with return instructions on December 22, 2003. All consignees responded.
- Quantity
- 4400
- Distribution
- The firm was able to determine that the product was distributed to 3 customers: Long Beach Memorial, Long Beach, CA; Potomac Hospital, Woodbridge Prince William, VA; and St. Joseph Hospital, Orange, CA.
- Lot, serial or model codes
- Batch # 3218665
- 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