FDA Enforcement Class II Terminated

Sterile Nail Clipper Concave Edge (67710)

Recall: Z-1719-2019 · Reported June 12, 2019

Enforcement

Recall Number
Z-1719-2019
Event ID
82667
Classification
Class II
Status
Terminated
Product Type
Devices
Firm
Centurion Medical Products Corporation
Voluntary / Mandated
Voluntary: Firm initiated
Initial Notification
Letter
Report Date
June 12, 2019
Initiation Date
March 29, 2019
Classification Date
June 4, 2019
Termination Date
May 8, 2020
Address
100 Centurion Way, Williamston, MI, 48895-9086, United States

Description

Sterile Nail Clipper Concave Edge (67710)

Reason

Compromised seal on the sterile barrier pouch.

Code Info

Lot 2018120701, exp 2023-11-30

Distribution

US nationwide distribution.