REF CMS-CT6T225, 6F Triple Lumen CT PICC with M.S.T. Components Product Usage: Power injectable infusion PICC insertion kits
This recall has been terminated (originally issued February 28, 2013).
- Recall Initiated
- December 13, 2012
- Posted
- February 28, 2013
- Terminated
- July 31, 2013
- Recall Number
- Z-0898-2013
- Quantity
- 785
- Firm Location
- Harleysville, PA
- Official Source
- View on FDA website ↗
Reason for Recall
The affected 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.
Distribution
USA Nationwide Distribution including the state of PA.
Lot / Code Info
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.
Root Cause
Nonconforming Material/Component
Action Taken
Medcomp sent a notification letter dated December 13, 2012 via email to all affected customers. The letter identified the affected product, problem and actions to be taken. For questions or concerns call 215-256-4201
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