Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Inject 10 Coronary Control Syringe (CCS), 10ml

FDA Recall Z-0912-03 · Posted 2003-06-05

Recalling FirmMerit Medical Systems, Inc
Recall StatusTerminated
Product CodeFMF
Date Initiated2003-05-16
Date Terminated2003-07-21
Product Quantity7257 units

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.

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.

↑