Recall Z-1421-2022— CooperSurgical, Inc.

Name: FDA recall Z-1421-2022
Creator: U.S. Food and Drug Administration
Published: 2022-06-13

Class II · Ongoing

Class II FDA medical device recall by CooperSurgical, Inc., initiated 2022-06-13. It names one FDA 510(k) clearance: K092963. Product: LifeGlobal Fast Freeze Thawing Kit, Model No. GFT5-055. Reason: There was translation error in the Spanish version of the IFU where the Spanish version instructs the user to leave the blastocyte to air thaw for 5 minutes rather than the correct 5 seconds as indicated in the English version..

Recalling firm: CooperSurgical, Inc.
Classification: Class II
Status: Ongoing
Initiated: 2022-06-13
Firm location: Trumbull, CT, United States

510(k) clearances named in this recall

1 on FDA's record

K092963 — GLOBAL BLASTOCYST VITRIFICATION KIT & VITRIFICATION THAWING KIT - BASED ON S3Genx Intl., Inc.·cleared 2011-01-14

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

LifeGlobal Fast Freeze Thawing Kit, Model No. GFT5-055

Reason for recall

There was translation error in the Spanish version of the IFU where the Spanish version instructs the user to leave the blastocyte to air thaw for 5 minutes rather than the correct 5 seconds as indicated in the English version.

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