Device product
REF CMS-CT6T225, 6F Triple Lumen CT PICC with M.S.T. Components Product Usage: Power injectable infusion PICC insertion kits
Z-0898-2013
Product summary
- Event
- Event 64235
- Status
- Terminated
- Classification
- Class II
- Quantity
- 785
- Official record key
device-enforcement:Z-0898-2013
Official wording
Reason: 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.
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: USA Nationwide Distribution including the state of PA.
Derived failure modes
-
Unknown
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.