FDAClass IIISeptember 28, 2016

Sage In-Vitro Fertilization- CSC recall

Sage In-Vitro Fertilization- CSC (Choline Substituted Cryopreservation) Thawing Medium Product Number: ART-8018 Intended for use in freezing embryos.…

Why was Sage In-Vitro Fertilization- CSC recalled?

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

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

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

Product
Sage In-Vitro Fertilization- CSC (Choline Substituted Cryopreservation) Thawing Medium Product Number: ART-8018 Intended for use in freezing embryos.…
Recalling firm
CooperSurgical, Inc.
Quantity
4 units
Distribution
Nationwide Distribution to CA, GA, and NY
Recall date
September 28, 2016
Classification
Class III
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls