Medical Device Thawing Kit Recalls Due to Spanish Instruction Translation Error
CooperSurgical recalls its LifeGlobal Fast Freeze Thawing Kit due to a Spanish instruction translation error that specifies 5 minutes instead of 5 seconds for blastocyte air thawing, affecting 403 units.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall involving a critical instruction error that could affect specimen viability and medical procedure outcomes. No illnesses, injuries, or deaths have been reported, limiting the score per the rubric's guidance that theoretical risks without reported harm score at most 3.
Plain-English summary
CooperSurgical, Inc. is recalling the LifeGlobal Fast Freeze Thawing Kit, Model No. GFT5-055, due to a translation error in the Spanish-language Instructions for Use (IFU). The Spanish version of the IFU incorrectly instructs users to allow blastocytes to air thaw for 5 minutes, while the correct procedure specified in the English version requires only 5 seconds of air thawing.
This discrepancy could result in improper thawing of embryos used in assisted reproductive procedures, potentially affecting the viability and quality of the specimens. The error affects 403 units distributed across multiple U.S. states (including California, Florida, New York, Texas, and others) and internationally in Belgium, Canada, Croatia, Netherlands, Portugal, and Spain.
Lot numbers affected by this recall include 21335060, GFT5-200218U, and GFT5-201026U. Users of this device should immediately verify that they are following the English version of the IFU or contact CooperSurgical for a corrected Spanish translation. No illnesses or injuries have been reported in connection with this recall.
The recalled product
- Product
- LifeGlobal Fast Freeze Thawing Kit, Model No. GFT5-055
- Manufacturer
- CooperSurgical, Inc.
- Category
- Medical Device — Embryo Thawing
- Hazard
- translation-error
- instruction-error
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- GFT5-200218U
- GFT5-201026U
Distribution
Distributed in 31 states:
- 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
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