Manifold Custom Kit. Label reads in part: ''CUSTOM KIT...MERIT MEDICAL''. Latex free, Sterile if package is unopened or undamaged. Part # K09-07862B, # K09-07873, #K09-02498F, #K09-07828b, #K09-00970J, #K09-06383B, #K09-07002A, #K09-04734D, #K09-00794K, and #K09-08037A.
FDA Recall Z-0141-04 · Posted 2003-11-19
Recalling FirmMerit Medical Systems, Inc
Recall StatusTerminated
Product CodeDQO
Date Initiated2003-10-01
Date Terminated2004-02-02
Product Quantity1927 units
Reason for Recall
There is a potential for the PETG blister trays to bond together with varying degrees of attachment. The potential for non-sterility exists when the attached trays are seperated by force and holes or cracks are generated in the seperated trays.
Firm Action
Merit notified sales representatives, domestic and international accounts and dealers immediately by letter dated October 3, 2003. The manufacturer requests that the use of the affected inventory should immediately cease and that on-hand units should be promptly isolated from general inventory for simultaneous inspection by a site representative and a Merit sales representative.
Root Cause
Other
Distribution Pattern
Distributed nationwide. International distribution includes Canada, Japan, Korea, England and France.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.