FDA recall Z-0551-2021

Product

PROKERA Plus, non-sterile - Product Usage: Biologic corneal bandage.

Reason for recall

Potential exposure of product to microbial contamination.

Distribution

US Nationwide distribution including in the states of FL, MN, NY, NC, SC, NJ, GA, PA, MD, DC, OH, WA, MI, CO, KS, TN, ME, AL, AR, TX, KY, MA, CA, CT, and OK.

Key facts

Status

Terminated

Initiation date

2020-11-10

Report date

2020-12-16

Termination date

2023-07-06

Voluntary/Mandated

Voluntary: Firm initiated

Location

Doral, FL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0551-2021