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Terminated

Custom Kit, Sterile EO, Rx Only, Catalog No. K09-09815, Manufacturer: Merit Medical Systems, Inc. South Jordan, Utah 84095, USA,

FDA Recall Z-0557-2011 · Posted 2010-12-08

Recalling FirmMerit Medical Systems, Inc.
Recall StatusTerminated
Product CodeDQO
Date Initiated2010-10-25
Date Terminated2012-03-23
Product Quantity1033 units

Reason for Recall

Defective custom kits may draw in air during use which may compromise patient safety and affect treatment. The valve's fixed luer may be over- or under-tightened, causing leaking at the bond joint.

Firm Action

Merit issued an Urgent Product Recall Notice letter dated October 25, 2010 to consignees. Copnsignees were instructed to quarantine the product immediately for return and to notify customers of recall activity and instruct them to return product.. All distributors and customers are to complete and return a Recall Notification Form. For further information about this recall, contact Merit at 800 356-3748.

Root Cause

Process control

Distribution Pattern

Nationwide Distribution in the states of CA, IL, IN, and UT.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K913682MERIT CUSTOM KITMerit Medical Systems, Inc. · 1991-11-15

Official Source

View FDA Recall →

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

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