FDA recall Z-2112-2020

Product

CooperSurgical Dilator/Sound Set, Rx only, Sterile/EO, Made in South Korea, P/N MX21

Reason for recall

The seal of the sterile pouch may be compromised on one lot of the Milex Cervical Dilators.

Distribution

Distribution to North America including the following states: AZ, CA, CT, DC, DE, FL, GA, IA, IN, MA, MI, MN, MO, NC, NH, NY, OH, OK, PA, SC, TN, TX, UT, VA, WI

Key facts

Status

Terminated

Initiation date

2020-04-09

Report date

2020-06-03

Termination date

2021-05-11

Voluntary/Mandated

Voluntary: Firm initiated

Location

Trumbull, CT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2112-2020