Merit Medical Systems, Inc. Prelude Pro Sheath Introducer REF/CAT No.: PRO-6F-11-035 Prelude PRO SHEATH INTRODUCER 6F 11 cm to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries.
FDA Recall Z-0519-2010 · Posted 2009-12-14
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Recalling FirmMerit Medical Systems, Inc.
Recall StatusTerminated
Product CodeDRE
Date Initiated2009-09-29
Date Terminated2009-12-15
Product Quantity5 Sheath Introducers
Reason for Recall
Potential sterility breach caused by excessive shipment damage.
Firm Action
Merit Medical Customers were contacted directly by phone and letter on 9/29/09. Customers were instructed to identify and quarantine all unused affected product. Further information was available at 801-208-4365.
Root Cause
Other
Distribution Pattern
US (AL, LA, MO, KY, TN, GA). 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.
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