Recall Z-1367-2019 ยท MQH Microtools, Assisted Reproduction (Pipettes)
CooperSurgical, Inc.
ICSI MICROPIPETTE CooperSurgical part number: MICC001-30-B1.0
| Date | Mar 27, 2019 |
| Status | Terminated |
| Reason | ICSI CUSTOM MICROPIPETTES the thirty-degree bend is absent |
| Root cause | Under Investigation by firm |
| Action | CooperSurgical issued recall letter dated March 27, 2019 identified problem and action to take: discontinue use of this discrepant product, quarantine the product, and complete the Acknowledgement and Receipt Form to arrange for either a product replacement or credit to your account through CooperSurgical. Contact: 203-601-5200 ext. 3300. |
| Quantity | 480 units |
| Distribution | Foreign: Denmark, Italy, Sweden |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K990847 | INTRACYTOPLASMIC SPERM INJECTION MICROPIPETS (ICSI) SPERMATID ICSI MICROPIPETS, HOLDING MICROPIPETS, ASSISTED HATCHING M Humagen Fertility Diagnostics, Inc., Jul 14, 1999 |