Recall Z-0937-2013
Vygon Corporation · initiated December 17, 2012
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: 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.
Reason for recall
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.
FDA-determined cause: Component change control
Action taken
Churchill Medical Systems sent a letter to their consignees on December 19, 2012.
Details
- Recall number
- Z-0937-2013
- Initiated
- December 17, 2012
- Posted by FDA
- March 11, 2013
- Terminated
- January 14, 2014
- Product code
- LJS – Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
- Quantity
- 210
- Distribution
- Product was distributed to 4 hospitals (under one hospital network) within the State of Pennsylvania
- Recalling firm
- Vygon Corporation, Lansdale, PA