BD Vacutainer Luer-Lok Access Device recallZ-0253-2007 · Becton Dickinson & Company · initiated Sep 8, 2006
Terminated All recalls posted in December 2006
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Becton Dickinson & Company or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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 category: Other
What the company is doing
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
Recall details
- Recall number
- Z-0253-2007
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Sep 8, 2006
- Posted by the FDA
- Dec 6, 2006
- Recalling firm
- Becton Dickinson & Company
- Quantity
- 1,744,400
- Product code
- JKA
- FDA submissions
- K991088
- Distribution
- Worldwide, including USA, Canada, and Australia.
Product description
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
Code information (models, lots, serial numbers)
Show the full code information (1k characters)
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
Other devices under the same FDA submission
2 devices cleared under K991088 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- BD Vacutainer® Blood Transfer Device Holder 364880Becton, Dickinson And Company · Tubes, vials, systems, serum separators, blood collection186 reports
- BD Vacutainer® Luer-Lok™ Access Device Holder 364902Becton, Dickinson And Company · Tubes, vials, systems, serum separators, blood collection1 recall115 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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