Medical Action Industries Inc Medical Action Industries, Dialysis Kit, using BD Q-Syte Luer Access Split Septum (BD #385100), Part number: 57977. Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Medical Action Industries, Dialysis Kit, using BD Q-Syte Luer Access Split Septum (BD #385100), Part number: 57977.
Brand
Medical Action Industries Inc
Lot Codes / Batch Numbers
Part number: 57977, Lot numbers: 62394, 63042 and 64820.
Products Sold
Part number: 57977, Lot numbers: 62394, 63042 and 64820.
Medical Action Industries Inc is recalling Medical Action Industries, Dialysis Kit, using BD Q-Syte Luer Access Split Septum (BD #385100), Part due to Manufacturing defect may allow air entry into a central venous catheter, possibly resulting in an air embolism.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Manufacturing defect may allow air entry into a central venous catheter, possibly resulting in an air embolism.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026