Custom 72inch Spike LG Bore Sub, REF/CAT 520016, for use with fluid administration sets, Merit Medical Systems, Inc., South Jordan, Utah 84095.
FDA Recall Z-0845-2007 · Posted 2007-05-31
Recalling FirmMerit Medical Systems, Inc.
Recall StatusTerminated
Product CodeFMG
Date Initiated2007-04-17
Date Terminated2008-05-05
Product Quantity400 units
Reason for Recall
Male luer in fluid administration sets may crack due to inadequate molding process
Firm Action
Consignees were notified by letter on 04/17/2007 and instructed to quarantine and return any unused product.
Root Cause
Other
Distribution Pattern
CA, IL, NJ, NY. No military, government or foreign 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.