Medical Action Industries, Venous Access Tray, using BD… recallZ-1074-2010 · Medical Action Industries Inc · initiated Nov 6, 2009
Terminated All recalls posted in March 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 Medical Action Industries Inc 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: Nonconforming Material/Component
What the company is doing
On 11/6/2009 a letter was drafted and sent by email to three (3) Medical Action Industries customers. They were instructed to return the recalled products in inventory to MAI. They further advised, if the product was distributed to notify their customer, inform them of the recall and instruct them to return the affected lots to MAI.
Recall details
- Recall number
- Z-1074-2010
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Nov 6, 2009
- Posted by the FDA
- Mar 30, 2010
- Recalling firm
- Medical Action Industries Inc
- Quantity
- 4,280 kits
- Product code
- FPA
- FDA submissions
- K013621
- Distribution
- Nationwide distribution
Product description
Medical Action Industries, Venous Access Tray, using BD Q-Syte Luer Access Split Septum (BD #385100)), Part number: 69498.
Code information (models, lots, serial numbers)
Part number: 69498, Lot numbers: 62282, 69902, 70350, 70854 and 72108.
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 53880).
- Z-1073-2010 · TerminatedMedical Action Industries, IV Start Bundle Kit, using MPS Acacia with BD Q-Syte (BD #385151), Part number: 69946B.
- Z-1075-2010 · TerminatedMedical Action Industries, Dialysis Kit, using BD Q-Syte Luer Access Split Septum (BD #385100), Part number: 57977.
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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