BD Vacutainer Luer Adapter recallZ-1462-06 · Becton Dickinson & Company · initiated Jun 21, 2006
Terminated All recalls posted in September 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
Firm received complaints indicating failure of the Non-Patient (NP) sleeve to function properly. This sleeve covers the cannula and prevents leakage during blood collection.
FDA root cause category: Other
What the company is doing
BD sent out recall notifications on 6/21/2006 to distributors and their direct account customers.
Recall details
- Recall number
- Z-1462-06
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Jun 21, 2006
- Posted by the FDA
- Sep 9, 2006
- Recalling firm
- Becton Dickinson & Company
- Quantity
- 3,324,000 units
- Product code
- JKA
- FDA submissions
- K991088
- Distribution
- World wide-Products are distributed nationwide to distributors and direct accounts. The products are also distributed internationally to the following locations: Japan, Australia, Canada, Hong Kong, New Zealand. For European distribution, the products are shipped to Temse located in Belgium who handles the recall. Temse has been identified as recalling only the following products and lots: Catalog Number 364896 (Direct Draw Adapter), lots 5311376, 5312193, 5312201. Catalog Number 367300 (Luer Adapter), lots 5307894, 5307896, 5307900. Government accounts include the VAMC in Erie, PA;
Product description
BD Vacutainer Luer Adapter; Catalog #367290 and #367300.
Code information (models, lots, serial numbers)
Catalog No: 367290 Lot Number 5305585; Catalog No: 367300 Lot Numbers 5307894; 5307896; 5307900. For European distribution, the products are shipped to Temse located in Belgium who handles the recall. Temse has been identified as recalling only the following products and lots: Catalog Number 364896 (Direct Draw Adapter), lots 5311376, 5312193, 5312201. Catalog Number 367300 (Luer Adapter), lots 5307894, 5307896, 5307900.
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
Other products in the same recall event
The FDA groups related products into one recall event (event 35831).
- Z-1461-06 · TerminatedBD Vacutainer Blood Collection Assembly with BD Blunt Plastic Cannula; Catalog #303380.
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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