FDA recall Z-2337-2018

Product

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

Distributed to accounts in AL, CA, FL, IA, IN, MI, MO, NC, NY, SD, TN, and TX.

Key facts

Status

Terminated

Initiation date

2018-04-09

Report date

2018-07-11

Termination date

2019-04-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Somerset, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2337-2018