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Terminated

Custom Angiographic Kit

FDA Recall Z-0622-03 · Posted 2003-03-06

Recalling FirmMerit Medical Systems, Inc
Recall StatusTerminated
Product CodeDQO
Date Initiated2003-02-13
Date Terminated2003-03-07
Product Quantity82 kits.

Reason for Recall

A recent design change feature in the cap closure design for stopcocks in tubing convenience kits could preclude proper sterilization.

Firm Action

Consignees were notified by phone and FAX on 2/12/2003.

Root Cause

Other

Distribution Pattern

FL and Japan.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K973230MONARCH (IN 2125)/INTELLISYSTEM (IN 1125)Merit Medical Systems, Inc. · 1997-11-25K934123STOPCOCK (ONE-PORT MANIFOLD)Merit Medical Systems, Inc. · 1993-11-23K913682MERIT CUSTOM KITMerit Medical Systems, Inc. · 1991-11-15K883718MERIT HI-FLEX(TM)Merit Medical Systems, Inc. · 1989-01-30

Official Source

View FDA Recall →

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

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