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Terminated

Medical Action Industries, Venous Access Tray, using BD Q-Syte Luer Access Split Septum (BD #385100)), Part number: 69498.

FDA Recall Z-1074-2010 · Posted 2010-03-30

Recalling FirmMedical Action Industries Inc
Recall StatusTerminated
Product CodeFPA
Date Initiated2009-11-06
Date Terminated2011-06-01
Product Quantity4,280 kits

Reason for Recall

Manufacturing defect may allow air entry into a central venous catheter, possibly resulting in an air embolism.

Firm 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.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Nationwide distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K013621BD SAF-T PRN LUER ACTIVATED VALVE, MODEL 385100Becton Dickinson Infusion Therapy Systems, Inc. · 2002-04-16

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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