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Terminated

BD Vacutainer Push Button Blood Collection Set; REF 367324 Rx only, 23 G x 3/4" x 12 " (0.6 x 19 mm x 305 mm); BD Vacutainer Push Button Blood Collection Set without Multiple Sample Luer Adaptor, Sterile, Rx only, 21 G x 3/4 x 12" 0.8 x 19 mm x 305 mm Blood collection system.

FDA Recall Z-3028-2011 · Posted 2011-08-16

Recall StatusTerminated
Product CodeKST
Date Initiated2011-04-22
Date Terminated2012-06-06
Product Quantity1,744,000

Reason for Recall

BD Vacutainer Push Button Blood Collection Set can potentially undergo cannula separation from the hub.

Firm Action

BD Diagnostics sent a "Lot Specific Product Recall" letter dated April 22, 2011 to all affected customers. The letter asked customers return any affected product and provides instructions for its return. The letter ask customers return the attached Packaging List with the shipment. For question on this recall contact BD Diagnostics at (201) 847-5117.

Root Cause

Device Design

Distribution Pattern

Nationwide (USA) Distribution.

Official Source

View FDA Recall →

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

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