BD Q-Syte, Luer Access Split-Septum, 0.10 ml, REF 385100… recallZ-0750-2010 · Becton Dickinson Medical Systems · initiated Oct 19, 2009
Terminated All recalls posted in February 2010
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 Medical Systems 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
Manufacturing defect may allow air entry into a central venous catheter, possibly resulting in an air embolism.
FDA root cause category: Process control
What the company is doing
Consignees were notified by B-D Urgent Medical Device Recall letter on 10/28/2009 and asked to return all unused affected lots. For information, call the company at 800-453-4538, option 2, extension 2341. Another letter was sent to all affected customers on 02/08/2010 notifying them of the extension of the recall to include Nexiva products. A response card was included to be returned whether or not product was on hand. B-D issued a press release on Febriuary 8, 2010. It can be found on www.bd.com at http://www.bd.com/contentmanager/b_article.asp?Item_ID=24486&ContentType_ID=1&BusinessCode=20001&d=BD+Worldwide&s=&dTitle=&dc=&dcTitle=
Recall details
- Recall number
- Z-0750-2010
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Oct 19, 2009
- Posted by the FDA
- Feb 2, 2010
- Recalling firm
- Becton Dickinson Medical Systems
- Quantity
- 950,000 units
- Product code
- FPA
- FDA submissions
- K013621
- Distribution
- Nationwide distribution.
Product description
BD Q-Syte, Luer Access Split-Septum, 0.10 ml, REF 385100, Becton Dickinson Infusion Therapy Systems Inc.
Code information (models, lots, serial numbers)
Lot Numbers 8268863, 8269020, 8275798, 8308321, 8308323, 8309553, 8331937, 8331940, 8354558, 9007921, 9009643, 9009646, 9028838, 9035029, 99035032.
Other devices under the same FDA submission
5 devices cleared under K013621 — 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 Q-Syte 385100Becton, Dickinson And Company · Set, administration, intravascular1 death971 reports
- BD Q-Syte 385102Becton, Dickinson And Company · Set, administration, intravascular269 reports
- BD Q-Syte 385101Becton, Dickinson And Company · Set, administration, intravascular27 reports
- BD Q-Syte 385108Becton, Dickinson And Company · Set, administration, intravascular18 reports
- Q-Syte 385103Becton, Dickinson And Company · Set, administration, intravascular4 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 53749).
- Z-0751-2010 · TerminatedBD Q-Syte Extension Set, 15cm Std Bore, P.V. 1.14 ml Luer-Lok, REF 385101, Becton Dickinson Infusion Therapy Systems Inc.
- Z-0752-2010 · TerminatedBD Q-Syte Extension Set, 15 cm, P.V. 0.21 ml, REF 385102, Becton Dickinson Infusion Therapy Systems Inc.
- Z-0753-2010 · TerminatedBD Q-Syte Vial Access Adapter, 0.16 ml, REF 385108, Becton Dickinson Infusion Therapy Systems Inc.
- Z-0754-2010 · TerminatedMPS Acacia Extension Set, 15cm RightBore-18, Spin Nut w/BBD Q-Syte, REF 385150,
- Z-0755-2010 · TerminatedMPS Acacia Extension Set, 15cm Small Bore, Spin Nut w/BD Q-Syte, REF 385151
- Z-0756-2010 · TerminatedMPS Acacia Tri-Extension Set, 15cm Small Bore, Spin Nut w/BD Q-Syte, REF 385164
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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