Device product
Pediatric Two-Lumen Central Venous Catheterization Kit with Blue FlexTip ARROWg+ard Blue Catheter, REF AK-25502 Product Usage; Provide short-term (< 30 days) central venous access for treatment of diseases or conditions requiring central venous access
Z-0053-2020
Product summary
- Event
- Event 82984
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3,143
- Official record key
device-enforcement:Z-0053-2020
Official wording
Reason: Lidstock contains a labeling error. The lidstock shows the catheter cross section of the gauge (GA) values in a reversed manner.
Code information: Lot/Batch Numbers: 13F18C0374, 13F18H0580, 13F18D0504, 13F18L0507, 13F18E0380, 13F18L0714, 13F18G0180, 13F18L0936, 13F18G0480
Distribution pattern: US Nationwide Distribution
Derived failure modes
-
Labeling or packaging
labeling error