Device product
SunTech Medical Disposable, Neonate #4, 1-Tube, Male Bayonet, Blood Pressure Cuffs, Box of 20
Z-2277-2019
Product summary
- Event
- Event 83070
- Status
- Terminated
- Classification
- Class II
- Quantity
- 80 total cuffs affected; 4 Boxes of 20 cuffs
- Official record key
device-enforcement:Z-2277-2019
Official wording
Reason: Product is mislabeled. The label on the package is for a size #4 cuff, but the incorrect size #3 cuff was placed in the package.
Code information: Catalog # 98-0400-98 Lot Number: A4H201
Distribution pattern: Pakistan
Derived failure modes
-
Labeling or packaging
mislabeled