Z-1667-2021 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- May 26, 2021
- Initiation Date
- April 7, 2021
- Termination Date
- June 1, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- N/A
Product Description
REF CK000516, Groshong NXT ClearVue Catheter with Sherlock 3CG Tip Positioning System (TPS) Stylet, Full Kit, 4F, Single-Lumen, TPS, CE 2797, UDI: (01)10801741107891 - Product Usage: is designed for use when central venous catheterization is prescribed.
Reason for Recall
Catheters contain two issues: 1. the inner diameter of the distal connector may be reduced resulting in inability to pass the catheter through the connector and 2. the catch slot on the distal connecter may be deformed resulting in the inability to properly lock
Distribution Pattern
Worldwide distribution - US Nationwide distribution in the states of AK, AL, CA, CO, FL, GA, IA, IL, IN, KS, KY, LA, MA, MN, MO, MT, NC, ND, NE, NH, NJ, NY, OH, OK, OR, PA, SD, TN, TX, UT, VA, WA, WI and the countries of Australia, Belgium, Canada, China, Japan, Taiwan, Hong Kong, Malaysia, Chile, Bangladesh, Korea, Brazil, India, Singapore, Thailand.
Code Information
Lot No. redz3509 REEN4546 reep4145 reer0944 reer2048 rees1328 rees2108 rees3222 reeu1443 reeu2740 reeu3561 reew4312