UHF Cardiac Pigtail non-wirebraid, 7F, 110 cm, Angiographic Catheter, Sterile, Merit Medical.
FDA Recall Z-0158-04 · Posted 2003-11-27
Recalling FirmMerit Medical Systems, Inc
Recall StatusTerminated
Product CodeDQO
Date Initiated2003-11-05
Date Terminated2003-12-01
Product Quantity410 units
Reason for Recall
Angiographic catheter tips may separate during use.
Firm Action
All 7 consignees were contacted by their sales representatives on 11/5-7/2003.
Root Cause
Other
Distribution Pattern
FL, MI, NY, PA, TN, TX. No foreign, government, or military distribution.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.