Z-0602-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- February 21, 2018
- Initiation Date
- July 25, 2017
- Termination Date
- August 29, 2018
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2691 total
Product Description
ArrowADVANTAGE 5 Pressure Injectable Peripherally Inserted Central Catheter (PICC). Product Codes: PR-35041-HPHNM and CDA-35041-HPK1A.
Reason for Recall
Finished good kits may contain incorrect components. Kits that should contain a 5 FR 2 lumen catheter may contain a 4 FR single lumen catheter and kits that should contain a 4 FR single lumen catheter may contain a 5 FR 2 lumen catheter. This may cause a delay in treatment while a replacement catheter is obtained.
Distribution Pattern
US nationwide distribution.
Code Information
Lot/Batch Numbers: 13F16A0089, 13F16A0180, 13F17B0290, 23F16F0614.