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Recall Observatory FDA recall evidence

Device product

Churchill Medical Systems, Inc. A Vygon Company - All sizes of CMS-CT6T225 6F Triple Lumen CT PICC with M.S.T. Components, Peripherally Inserted Central Catheter.

Z-0937-2013

December 17, 2012

Class II

Product summary

Firm
Vygon Corporation
Event
Event 64458
Status
Terminated
Classification
Class II
Quantity
210
Official record key
device-enforcement:Z-0937-2013

Official wording

Reason: Product was packaged with the incorrect introducer needle. The kit label indicates a "safety" needle is included; the kits were packaged with a non-safety needle.

Code information: Lots numbers MBKQ640, exp 05/2015; MBKZ720, exp 05/2015; MBLJ290, exp 06/2015; MBLR100, exp 07/2015; MBLZ350, exp 09/2015; and MBMG250, exp 10/2015.

Distribution pattern: Product was distributed to 4 hospitals (under one hospital network) within the State of Pennsylvania

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Product was packaged with the incorrect introducer needle. The kit label indicates a "safety" needle is included; the kits were packaged with a non-safety needle.