Z-2164-2019 Class II Terminated

Recalled by Centurion Medical Products Corporation — Williamston, MI

FDA device recall Z-2164-2019 was initiated by Centurion Medical Products Corporation on July 1, 2019 and is designated Class II. Reason for recall: Potential for sterile packaging to be compromised The recall status is terminated (terminated June 26, 2020). Affected quantity: 168 each.

Recall Details

Product Type
Devices
Report Date
August 14, 2019
Initiation Date
July 1, 2019
Termination Date
June 26, 2020
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
168 each

Product Description

CIRCUMCISION TRAY Kit Code: CIT2650H - Product Usage: Kit is used for performing circumcision procedures on newborns.

Reason for Recall

Potential for sterile packaging to be compromised

Distribution Pattern

US Nationwide distribution in the states of AZ, CA, FL, GA, IL, KY, MA, MD, MI, NC, NH, NY, OH, SC, TX, TN, VA, WA, WI.

Code Information

Lot # 2019051390 Exp: 8/31/2021