Recall Z-1108-2022 ยท MQK Labware, Assisted Reproduction
CooperSurgical, Inc.
VITRIGUARD, CARRIER, CLEAR; Model. No. 43782001 The VitriGuard device is a cryopreservation storage device composed of a stick and cap.
| Date | Apr 1, 2022 |
| Status | Open, Classified |
| Reason | Products in this lot may have compromised barrier seals, introducing a risk to sterility. |
| Root cause | Process control |
| Action | On April 1, 2022, the firm distributed URGENT Medical Device Safety Notices to affected customers. Customers were informed of the potential breach to the sterile barrier of the affected lot. Customers should discontinue use of the affected lot and quarantine the product for return to CooperSurgical. If you have additional questions, please contact a CooperSurgical Product Surveillance representative at 203.601.5200 Ext. 3300 or email the firm at recall@coopersurgical.com. |
| Quantity | 2,340 (US only) |
| Distribution | Domestic distribution to AZ, CA, FL, IL, MI, MO, NY, OR, TX, and WV. No foreign distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K162833 | VitriGuard Origio A/S, Feb 16, 2017 |