Device product
NovaPlus Infant Heel Warmer, Instant Squeeze Activation, Catalog Number V11460-010
Z-2147-2023
Product summary
- Event
- Event 92529
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 44,500 units
- Official record key
device-enforcement:Z-2147-2023
Official wording
Reason: Cardinal Health has received an increase in burst/leaking complaints from mid-April to May regarding the above listed lot of the Novalplus Infant Heel Warmer with tape.
Code information: UDI/DI (Case) 50885380057586, (Box) 20885380057585, (EA) 10885380057588, Lot Number V2S056
Distribution pattern: US Nationwide distribution.
Derived failure modes
-
Unknown
Cardinal Health has received an increase in burst/leaking complaints from mid-April to May regarding the above listed lot of the Novalplus Infant Heel Warmer with tape.