LifeGlobal Fast Freeze Thawing Kit recall
LifeGlobal Fast Freeze Thawing Kit, Model No. GFT5-055
Why was LifeGlobal Fast Freeze Thawing Kit recalled?
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.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- LifeGlobal Fast Freeze Thawing Kit, Model No. GFT5-055
- Recalling firm
- CooperSurgical, Inc.
- Quantity
- 403 units
- 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
- Recall date
- July 27, 2022
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (device)