CooperSurgical, Inc. Recall 90469
Description: LifeGlobal Fast Freeze Thawing Kit, Model No. GFT5-055
CooperSurgical, Inc. Recall 90469 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | Z-1421-2022 |
| Event ID | 90469 |
| Event Description | LifeGlobal Fast Freeze Thawing Kit, Model No. GFT5-055 |
| Product Type | Devices |
| 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 |
| Recall 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. |
| Device Classification | 20220727 |
| Device 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 |
| Center Classification Date | 20220720 |
| Recall Initiation Date | 20220613 |
| Recalling Firm | CooperSurgical, Inc. |
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