Medical Action Industries, Dialysis Kit, using BD Q-Syte Luer Access Split Septum (BD #385100), Part number: 57977.
- Company
- Medical Action Industries Inc
- Recall Initiated
- November 6, 2009
- Posted
- March 30, 2010
- Terminated
- June 1, 2011
- Recall Number
- Z-1075-2010
- Quantity
- 2,520 kits
- Firm Location
- Arden, NC
Reason for Recall
Manufacturing defect may allow air entry into a central venous catheter, possibly resulting in an air embolism.
Distribution
Nationwide distribution
Lot / Code Info
Part number: 57977, Lot numbers: 62394, 63042 and 64820.
Root Cause
Nonconforming Material/Component
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.
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