Z-0034-2007

BD Vacutainer Push Button Blood Collection Set with Pre-attached Holder. Non-pyrogenic 100. Rx only, sterile...

Name: Z-0034-2007 BD Vacutainer Push Button Blood Collection Set with Pre-attached Holder. Non-pyrogenic 100. Rx only, sterile...
Creator: Becton Dickinson & Company
Published: 2006-08-11
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2006-08-11 / Terminated / root cause: packaging

FDA source

Becton Dickinson & Company began a recall of 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... on 2006-08-11. The reason FDA records is "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0034-2007
Status: Terminated
Initiated: 2006-08-11
Posted: 2006-10-12
Terminated: 2007-05-08
Recalling firm: Becton Dickinson & Co
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
Product code: JAK System, X-Ray, Tomography, Computed
Reason for recall: 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 tag: packaging
FDA 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 in commerce: 110,300 units
Distribution: Nationwide.
Product codes and lots: 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

Product code JAK

K011984Class IIBd Vacutainer Push Button Blood Colection SetBecton, Dickinson & CO / cleared 2001-08-29

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)