Recall Z-0100-2021— CooperSurgical, Inc.

Name: FDA recall Z-0100-2021
Creator: U.S. Food and Drug Administration
Published: 2020-09-08

Class II · Terminated

Class II FDA medical device recall by CooperSurgical, Inc., initiated 2020-09-08, terminated 2021-01-11. It names one FDA 510(k) clearance: K100367. Product: MediCult Vitrification Cooling Media, Model Number 12284001F. Reason: There is a discrepancy between the printing on the Product Tyvek label of the individual component packaging. The Chinese characters on the label indicates that it contains an Equilibration Medium (P/N: 12220001) rather than the Vitrification Medium (P/N: 12230001) as indicated on the remainder of the label..

Recalling firm: CooperSurgical, Inc.
Classification: Class II
Status: Terminated
Initiated: 2020-09-08
Terminated: 2021-01-11
Firm location: Trumbull, CT, United States

510(k) clearances named in this recall

1 on FDA's record

K100367 — MEDICULT VITRIFICATION COOLING/WARMING, MODEL REF: 1228, 1229Origio A/S·cleared 2010-08-27

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

MediCult Vitrification Cooling Media, Model Number 12284001F

Reason for recall

There is a discrepancy between the printing on the Product Tyvek label of the individual component packaging. The Chinese characters on the label indicates that it contains an Equilibration Medium (P/N: 12220001) rather than the Vitrification Medium (P/N: 12230001) as indicated on the remainder of the label.

Data sourced from openFDA. This site is unofficial and independent of the FDA.