Z-1075-2010

Medical Action Industries, Dialysis Kit, using BD Q-Syte Luer Access Split Septum (BD #385100), Part number...

Name: Z-1075-2010 Medical Action Industries, Dialysis Kit, using BD Q-Syte Luer Access Split Septum (BD #385100), Part number...
Creator: Medical Action Industries Inc
Published: 2009-11-06
License: https://open.fda.gov/license/

Medical Action Industries, Inc. 306 / initiated 2009-11-06 / Terminated / root cause: manufacturing process

FDA source

Medical Action Industries Inc began a recall of Medical Action Industries, Dialysis Kit, using BD Q-Syte Luer Access Split Septum (BD #385100), Part number: 57977 on 2009-11-06. The reason FDA records is "Manufacturing defect may allow air entry into a central venous catheter, possibly resulting in an air embolism". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1075-2010
Status: Terminated
Initiated: 2009-11-06
Posted: 2010-03-30
Terminated: 2011-06-01
Recalling firm: Medical Action Industries, Inc. 306
Product: Medical Action Industries, Dialysis Kit, using BD Q-Syte Luer Access Split Septum (BD #385100), Part number: 57977.
Product code: FPA Set, Administration, Intravascular
Reason for recall: Manufacturing defect may allow air entry into a central venous catheter, possibly resulting in an air embolism.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: 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.
Quantity in commerce: 2,520 kits
Distribution: Nationwide distribution
Product codes and lots: Part number: 57977, Lot numbers: 62394, 63042 and 64820.

Product code FPA

K013621Class IIBd Saf-T Prn Luer Activated Valve, Model 385100Becton Dickinson Infusion Therapy Systems, Inc. / cleared 2002-04-16

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)