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Terminated

ReliOn 0.5cc 30 g x 8mm Blister Pak U-100 syringe 30 gauge x 5/16" length, for subcutaneous injection of insulin.

FDA Recall Z-1226-2007 · Posted 2007-09-20

Recalling FirmBecton Dickinson & Company
Recall StatusTerminated
Product CodeFMI
Date Initiated2007-06-21
Date Terminated2008-06-03
Product Quantity644,500 units

Reason for Recall

Complaints received indicating open seals on blister paks, potentially compromising the sterility of the product.

Firm Action

Urgent Product Recall notifications were sent on 6/21/07 asking them to discontinue use of product, remove from inventory and complete Tracking Verification form.

Root Cause

Other

Distribution Pattern

Nationwide.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K024112BD INSULIN SYRINGEBecton, Dickinson & CO · 2003-01-09

Official Source

View FDA Recall →

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

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