LifeGlobal Fast Freeze Thawing Kit, Model No. GFT5-055
Check against the official notice below — it lists the full affected range.
CooperSurgical, Inc. is recalling 403 units of the LifeGlobal Fast Freeze Thawing Kit, Model No. GFT5-055, distributed across multiple U.S. states and several international countries including Canada, Spain, Belgium, the Netherlands, Portugal, and Croatia. The recall was initiated due to a translation error in the Spanish version of the instructions for use, which incorrectly instructs users to leave the blastocyte to air thaw for 5 minutes instead of the correct 5 seconds as specified in the English version.
The affected product lot numbers are 21335060, GFT5-200218U, and GFT5-201026U. The source document does not specify what action consumers should take in response to this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
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. Distribution: 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 Quantity: 403 units Lot/code info: UDI: (01)00815965020914 (17)220819 (10)GFT5-200218U (01)00815965020914 (17)220819 (10)GFT5-201026U (01)00815965020914 (17)220819 (10)GFT5-21335060 Lots: 21335060, GFT5-200218U, GFT5-201026U
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.