Z-0601-2018 Class II Terminated
FDA device recall Z-0601-2018 was initiated by Arrow International Inc on July 25, 2017 and is designated Class II. 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… The recall status is terminated (terminated August 29, 2018). Affected quantity: 2691 total.
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
ARROW PICC powered by ARROW VPS Stylet, Product Codes: CDC-35052-VPS and CDC-35041-VPS. Peripherally Inserted Central Catheter
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: 23F17A0038, 23F17A0040, 23F16M0059.