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Open, Classified

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

FDA Recall Z-1421-2022 · Posted None

Recalling FirmCooperSurgical, Inc.
Recall StatusOpen, Classified
Product CodeMQL
Date Initiated2022-06-13
Product Quantity403 units

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.

Firm Action

On June 13, 2022, the firm distributed Urgent Media Safety Notice letters to affected customers. Customers were informed that setting out a thawing blastocyte for 5 minutes may be detrimental to the survival of the blastocyte. Customers were asked to complete and return an acknowledgement form. Once the firm has received the completed form, they will provide the corrected IFU.

Root Cause

Error in labeling

Distribution Pattern

Domestic: USA AL, AZ, CA, CT, FL, GA, ID, IL, IN, KS, MA, MD, MI, MN, MO, MT, NC, NE, NJ, NV, NY, OH, OK, OR, PA, SC, TX, UT, VT, WA, WI, International: Belgium, Canada, Croatia, Netherlands, Portugal, Spain

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K092963GLOBAL BLASTOCYST VITRIFICATION KIT & VITRIFICATION THAWING KIT - BASED ON S3Genx Intl., Inc. · 2011-01-14

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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