Z-3199-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- September 26, 2018
- Initiation Date
- July 17, 2018
- Termination Date
- December 2, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1257 total
Product Description
4.5 Fr x 40 cm single-lumen PICC Kit, Product Code CDC-44041-VPS2, 5.5 Fr double-lumen PICC Kit, Product Code CDC-44052-VPS2
Reason for Recall
The products may contain the incorrect catheter. Kits that should contain a 4.5 Fr single-lumen catheter may contain a 5.5 Fr double-lumen catheter. Kits that should contain a 5.5 Fr double-lumen catheter may contain a 4.5 Fr single-lumen catheter. This issue may cause a delay in treatment while a replacement catheter is obtained.
Distribution Pattern
The products were distributed to the following US states: AL, AZ, CA, GA, MA, MD, ME, MI, NY, PA, RI, SC, VA, and WA.
Code Information
23F18B0428