Z-0253-2007

BD Vacutainer Luer-Lok Access Device Holder with Pre-Attached Multiple Sample Adapter Sterile, Do Not Reuse...

Name: Z-0253-2007 BD Vacutainer Luer-Lok Access Device Holder with Pre-Attached Multiple Sample Adapter Sterile, Do Not Reuse...
Creator: Becton Dickinson & Company
Published: 2006-09-08
License: https://open.fda.gov/license/

Becton Dickinson & Co / initiated 2006-09-08 / Terminated

FDA source

Becton Dickinson & Company began a recall of BD Vacutainer Luer-Lok Access Device Holder with Pre-Attached Multiple Sample Adapter Sterile, Do Not Reuse, Keep away from heat, Rx only Ref # 364902 200... on 2006-09-08. The reason FDA records is "Reports of failure of the Luer Lok Access Device to lock securely to certain catheter devices because the male luer taper surface is not within the specification". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0253-2007
Status: Terminated
Initiated: 2006-09-08
Posted: 2006-12-06
Terminated: 2007-05-08
Recalling firm: Becton Dickinson & Co
Product: BD Vacutainer Luer-Lok Access Device Holder with Pre-Attached Multiple Sample Adapter Sterile, Do Not Reuse, Keep away from heat, Rx only Ref # 364902 200 (4X50) BD Franklin Lakes, NJ 07417
Product code: JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Reason for recall: Reports of failure of the Luer Lok Access Device to lock securely to certain catheter devices because the male luer taper surface is not within the specification.
FDA root cause: Other
Action: Recall notification was sent 9/8/06 to all direct accounts and distributors by US mail, return receipt requested. Consignees were asked to send product back to BD with the packing slip and shipping labels enclosed
Quantity in commerce: 1,744,400
Distribution: Worldwide, including USA, Canada, and Australia.
Product codes and lots: UPC (01)30382903649021 Catalog # 364902 Lot # 6138499 Exp. 4/09 Catalog # 364902 Lot # 6144043 Exp. 4/09 Catalog # 364902 Lot # 6144082 Exp. 4/09 Catalog # 364902 Lot # 6144090 Exp. 4/09 Catalog # 364902 Lot # 6144128 Exp. 4/09 Catalog # 364902 Lot # 6150373 Exp. 4/09 Catalog # 364902 Lot # 6150365 Exp. 5/09 Catalog # 364902 Lot # 6153085 Exp. 5/09 Catalog # 364902 Lot # 6154356 Exp. 5/09 Catalog # 364902 Lot # 6154358 Exp. 5/09 Catalog # 364902 Lot # 6173027 Exp. 5/09 Catalog # 364902 Lot # 6173028 Exp. 5/09 Catalog # 364902 Lot # 6178307 Exp. 5/09 Catalog # 364902 Lot # 6178357 Exp. 5/09

Product code JKA

K991088Class IIVacutainer Brand Multiple Sample Luer Adapter, Blood Collection Sets and Safety-Lok Blood Collection, Safety Blood ColleBecton Dickinson Vacutainer Systems / cleared 1999-05-28

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)