Device product
Atrium 36Fr Right Angled Firm PVC Thoracic Catheter, (Pkg of 10) Part Number: 15236
Z-2346-2015
Product summary
- Event
- Event 71510
- Status
- Terminated
- Classification
- Class II
- Quantity
- 62 cases (10/cs)=620 units
- Official record key
device-enforcement:Z-2346-2015
Official wording
Reason: Inner pouches incorrectly labeled as part 8136, 36Fr Right Angled Thermosensitive PVC catheter, but are part 15236-36Fr Right Angled Firm PVC Catheter
Code information: Lot Number : ME215673 EXp: 2019/09
Distribution pattern: AZ, CA, LA. IN, NC, TN, TX, VA
Derived failure modes
-
Labeling or packaging
incorrectly labeled