Z-1574-2020 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- April 1, 2020
- Initiation Date
- October 1, 2019
- Termination Date
- February 18, 2022
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 650 Catheters
Product Description
1. Groshong 9.5 Dual-Lumen CV Catheter, Ref: 7726950, UDI: (01)00801741041570; 2. Groshong 9.5 F Dual-Lumen CV Catheter, REF: 7726954, UDI: (01)00801741041587
Reason for Recall
Firm has identified that the product may be at risk of incorrectly containing a tunneler with a barb tip meant to attach to a 6Fr catheter instead of the correct barb tip for a 9.6Fr catheter. This can result in a prolongation of operation.
Distribution Pattern
Worldwide distribution - US Nationwide distribution in the states of AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS,KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NJ, NM, NV, NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT,VA, VT, WA, WI, WV, WY and countries of Brazil, Canada, EMEA, Korea, Mexico, New Zealand.
Code Information
7726950 Lot # RECQ1106, RECR2195 7726954 Lot # RECU1837