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Terminated

Custom Kit, Left Heart Kit, REF/CAT No.: K09T-09576, Rx only, Merit Medical Systems Inc., South Jordan, Utah.

FDA Recall Z-0847-2007 · Posted 2007-05-31

Recalling FirmMerit Medical Systems, Inc.
Recall StatusTerminated
Product CodeFMG
Date Initiated2007-04-17
Date Terminated2008-05-05
Product Quantity17 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.

K915678MERIT ADMINISTRATION SETMerit Medical Systems, Inc. · 1992-07-30

Official Source

View FDA Recall →

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

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