Medical Action Industries, Dialysis Kit, using BD Q-Syte Luer Access Split Septum (BD #385100), Part number: 57977.
FDA device recall Z-1075-2010 · posted 2010-03-30 · Terminated
Recall details
- Recalling firm
- Medical Action Industries Inc
- Reason for recall
- Manufacturing defect may allow air entry into a central venous catheter, possibly resulting in an air embolism.
- Action taken
- 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.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- FPA
- Quantity affected
- 2,520 kits
- Distribution
- Nationwide distribution
- Date initiated
- 2009-11-06
- Date posted
- 2010-03-30
- Date terminated
- 2011-06-01
- Location
- Arden, NC
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BD SAF-T PRN LUER ACTIVATED VALVE, MODEL 385100 (K013621) | Becton Dickinson Infusion Therapy Systems, Inc. | 2002-04-16 |