Z-2337-2018 Class II Terminated
FDA device recall Z-2337-2018 was initiated by Terumo Medical Corp on April 9, 2018 and is designated Class II. Reason for recall: Two lots of product were released for distribution prior to the completion of all required validation and lot acceptance activities. Although sterile, products from these lots may not function as inte… The recall status is terminated (terminated April 19, 2019). Affected quantity: 240.
Recall Details
- Product Type
- Devices
- Report Date
- July 11, 2018
- Initiation Date
- April 9, 2018
- Termination Date
- April 19, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 240
Product Description
Angio-Seal Evolution Vascular Closure Device, Cat. No. C610135
Reason for Recall
Two lots of product were released for distribution prior to the completion of all required validation and lot acceptance activities. Although sterile, products from these lots may not function as intended and therefore should not be used.
Distribution Pattern
Distributed to accounts in AL, CA, FL, IA, IN, MI, MO, NC, NY, SD, TN, and TX.
Code Information
5980075, 5980077