Z-0053-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- October 16, 2019
- Initiation Date
- May 17, 2019
- Termination Date
- September 24, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,143
Product Description
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
Reason for Recall
Lidstock contains a labeling error. The lidstock shows the catheter cross section of the gauge (GA) values in a reversed manner.
Distribution Pattern
US Nationwide Distribution
Code Information
Lot/Batch Numbers: 13F18C0374, 13F18H0580, 13F18D0504, 13F18L0507, 13F18E0380, 13F18L0714, 13F18G0180, 13F18L0936, 13F18G0480