Device product
Cardinal Health Brand 120mL/53mm sterile specimen container with orange cap, 75 pieces/pack, 4 packs/case Catalog number: CHB13904
Z-0272-2020
Product summary
- Event
- Event 83762
- Status
- Terminated
- Classification
- Class II
- Quantity
- 2,979,600 each
- Official record key
device-enforcement:Z-0272-2020
Official wording
Reason: Cardinal Health branded specimen containers, may potentially contain plastic shavings on threaded surfaces between the closure and vial
Code information: Lot # 1236428, 1237502, 1237804, 1238412,1238880, 1239711, 1241129, 1242233, 1243303,1243863, 1246080,1246545,1247463,1248348, 1248489, 1249612, 1250496,1250723, 1251447,1251519, 1251993, 1253294
Distribution pattern: OH
Derived failure modes
-
Foreign material or chemical contamination
plastic shavings