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Terminated

Custom Kit

FDA Recall Z-0913-03 · Posted 2003-06-05

Recalling FirmMerit Medical Systems, Inc
Recall StatusTerminated
Product CodeDQO
Date Initiated2003-05-16
Date Terminated2003-07-21
Product Quantity20 kits

Reason for Recall

Cracks in the syringe barrels could allow for air aspiration into the syringe barrel.

Firm Action

On 5/16/2003, all distributors and consignees were notified by letter.

Root Cause

Other

Distribution Pattern

Nationwide. Foreign distribution to France, Malaysia, Taiwan, Dominican Republic.

Official Source

View FDA Recall →

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

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