CooperSurgical, Inc.: Medical Device Recall in 2016 - (Recall #: Z-2851-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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).

Product Classification:

Class III

Date Initiated: August 25, 2016

Date Posted: September 28, 2016

Recall Number: Z-2851-2016

Event ID: 75094

Reason for Recall:

Products contain international package insert and not the correct USA package insert

Status: Terminated

Product Quantity: 4 units

Code Information:

Lot no 16140184 expires April 2017 Lot no 15430149 expires Oct. 2016

Distribution Pattern:

Nationwide Distribution to CA, GA, and NY

Voluntary or Mandated:

Voluntary: Firm initiated