Device product
PICC/CVC Secure Dressing Change kit, Ref: 73775, Lot 213403, Sterile Single Use, Medical Action Industries, Inc., Arden, NC. This kit is used by clinicians to change dressings
Z-1036-2016
Product summary
- Event
- Event 73237
- Status
- Terminated
- Classification
- Class II
- Quantity
- 9 cases (180 kits)
- Official record key
device-enforcement:Z-1036-2016
Official wording
Reason: Misbranding; Due to the presence of CHG in the Tegaderm PICC/CVC dressing change convenience kit, which is not identified on the exterior labeling
Code information: Kit #73775, Lot 213403
Distribution pattern: Nationwide distribution to MO, NE and TX .
Derived failure modes
-
Labeling or packaging
Misbranding