Recall Z-1421-2022 ยท MQL Media, Reproductive
CooperSurgical, Inc.
LifeGlobal Fast Freeze Thawing Kit, Model No. GFT5-055
| Date | Jun 13, 2022 |
| Status | Open, Classified |
| 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. |
| Root cause | Error in labeling |
| 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. |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K092963 | GLOBAL BLASTOCYST VITRIFICATION KIT & VITRIFICATION THAWING KIT - BASED ON S3 Genx Intl., Inc., Jan 14, 2011 |