FDA Medical Device Recalls (openFDA)
Becton Dickinson & Company: BD Vacutainer Push Button Blood Collection Set with Pre-attached Holder. Non-pyrogenic 100. Rx only, sterile REF 368656 23G x 3/4'' x 12'' 0.6 x 19mm x 305mm ----- REF 367352 21G x 3/4'' x 12'' 0.8 x 19mm x 305mm
- Recall number
- Z-0034-2007
- Recalling firm
- Becton Dickinson & Company
- Product
- BD Vacutainer Push Button Blood Collection Set with Pre-attached Holder. Non-pyrogenic 100. Rx only, sterile REF 368656 23G x 3/4'' x 12'' 0.6 x 19mm x 305mm ----- REF 367352 21G x 3/4'' x 12'' 0.8 x 19mm x 305mm
- Status
- Terminated
- Initiated
- 2006-08-11
- Posted
- 2006-10-12
- Terminated
- 2007-05-08
- Reason
- A complaint was received regarding a BD blood collection set where the blister was noticeably warped. The seal width was below minimum specification. Some blisters could adhere together and crack upon separation. Some units may have pre-activated or have defects affecting package integrity.
- Root cause
- Other
- Action
- Recall notification were mailed out first class mail, return receipt requested, approximately 8/24/2006 to distributors, who were then asked to contact their customers.
- Quantity
- 110,300 units
- Distribution
- Nationwide.
- Lot, serial or model codes
- Catalog number 367352 Lot # 6100596 Catalog number 367352 Lot # 6100597 Catalog number 367352 Lot # 6152413 Catalog number 368656 Lot # 6090251 Catalog number 368656 Lot # 6094813 Catalog number 368656 Lot # 6094840 Catalog number 368656 Lot # 6111757 Catalog number 368656 Lot # 6121663 Catalog number 368656 Lot # 6146186
- 510(k) numbers
- ["K011984"]
- PMA numbers
- not on file
- Product code
- JAK
- 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