FDA Enforcement
Class II
Terminated
ARROW PICC powered by ARROW VPS Stylet, Product Codes: CDC-35052-VPS and CDC-35041-VPS. Peripherally Inserted Central Catheter
Recall: Z-0601-2018
·
Reported February 21, 2018
Enforcement
- Recall Number
- Z-0601-2018
- Event ID
- 78964
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Arrow International Inc
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- February 21, 2018
- Initiation Date
- July 25, 2017
- Classification Date
- February 13, 2018
- Termination Date
- August 29, 2018
- Address
- 2400 Bernville Rd, Reading, PA, 19605-9607, United States
Description
ARROW PICC powered by ARROW VPS Stylet, Product Codes: CDC-35052-VPS and CDC-35041-VPS. Peripherally Inserted Central Catheter
Reason
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.
Code Info
Lot/Batch Numbers: 23F17A0038, 23F17A0040, 23F16M0059.
Distribution
US nationwide distribution.
Quantity
2691 total