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Terminated

Merit MAK Mini Access Kit, 4 French (1.3mm)

FDA Recall Z-1310-04 · Posted 2004-08-04

Recalling FirmMerit Medical Systems, Inc
Recall StatusTerminated
Product CodeDRE
Date Initiated2004-07-20
Date Terminated2005-01-21
Product Quantity1924 kits

Reason for Recall

Firm received a report of an introducer sheath separating from its hub while in the patient. Surgery was successful in removal, even though the sheath kept breaking during the attempt.

Firm Action

Consignees were notified by phone and letter on 7/20/2004.

Root Cause

Other

Distribution Pattern

Nationwide, including VA facilities in MA, MI, NY, RI and TX. Argentina, Canada, China, Germany, Italy, Israel, Netherlands, New Zealand, Saudi Arabia, Scotland, Singapore, Thailand, United Arab Emirates.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K031691MERIT MAK (MINI ACCESS KIT)Merit Medical Systems, Inc. · 2003-09-03

Official Source

View FDA Recall →

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

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