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Terminated

10 ml Inject 10 Palm Pad, sterile

FDA Recall Z-0049-05 · Posted 2004-10-28

Recalling FirmMerit Medical Systems, Inc
Recall StatusTerminated
Product CodeFMF
Date Initiated2004-09-14
Date Terminated2005-03-31
Product Quantity25 syringes

Reason for Recall

Certain syringes exhibit a potential for air to be drawn into the syringe due to a dimensional mismatch.

Firm Action

All consignees were notified by telephone and letter on 9/14/2004. A second letter, dated 11/24/04, was also sent to consignees.

Root Cause

Other

Distribution Pattern

Nationwide. One VA facility in NC, one military hospital in GA. Foreign distribution to Canada, France, Japan, Netherlands.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K875196DISPOSABLE CORONARY CONTROL SYRINGE 12CCMerit Medical Systems, Inc. · 1988-02-11

Official Source

View FDA Recall →

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

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