FDAClass IIMarch 20, 2013

Churchill Medical Systems recall

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

Why was Churchill Medical Systems recalled?

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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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.

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…
Recalling firm
Vygon Corporation
Quantity
210
Distribution
Product was distributed to 4 hospitals (under one hospital network) within the State of Pennsylvania
Recall date
March 20, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls