FDA Medical Device Recalls (openFDA)
CooperSurgical, Inc.: Sage In-Vitro Fertilization- CSC (Choline Substituted Cryopreservation) Thawing Medium Product Number: ART-8018 Intended for use in freezing embryos. This product is intended for thawing of embryos frozen with ART-8017, CSC Freezing Medium. This kit is designed to be used in conjunction with the SAGE CSC Freezing Medium Kit (ART-8017).
- Recall number
- Z-2851-2016
- Recalling firm
- CooperSurgical, Inc.
- Product
- Sage In-Vitro Fertilization- CSC (Choline Substituted Cryopreservation) Thawing Medium Product Number: ART-8018 Intended for use in freezing embryos. This product is intended for thawing of embryos frozen with ART-8017, CSC Freezing Medium. This kit is designed to be used in conjunction with the SAGE CSC Freezing Medium Kit (ART-8017).
- Status
- Terminated
- Initiated
- 2016-08-25
- Posted
- 2016-09-20
- Terminated
- 2017-02-01
- Reason
- Products contain international package insert and not the correct USA package insert
- Root cause
- Packaging change control
- Action
- CooperSurgical sent an Advisory Notice dated August 25, 2016, to affected customers via UPS with confirmed delivery receipt. The letter identified the affected product and detailed the necessary actions to be taken by customers who carried the affected lots in their inventory. The advisory notification asked customers to replace the previously inserted incorrect Instructions for use (IFU) with the correct IFU sent with the advisory notification. For questions regarding this recall call 203-601-5200.
- Quantity
- 4 units
- Distribution
- Nationwide Distribution to CA, GA, and NY
- Lot, serial or model codes
- Lot no 16140184 expires April 2017 Lot no 15430149 expires Oct. 2016
- 510(k) numbers
- ["K991390"]
- PMA numbers
- not on file
- Product code
- MQL
- Firm FEI
- 1216677
- Firm city
- Trumbull
- Firm state
- CT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28