CooperSurgical Recalls Sage CSC Thawing Medium Due to Incorrect Package Insert
CooperSurgical, Inc. is recalling 4 units of Sage CSC Thawing Medium because the products contain an international package insert instead of the correct USA package insert.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The FDA classified this as a Class III recall, which the rubric defines as typically resulting in a score of 1 or 2 because it is unlikely to cause adverse health consequences. The issue is a documentation/packaging error (incorrect package insert) rather than a product defect or contamination.
Plain-English summary
CooperSurgical, Inc. is recalling 4 units of Sage In-Vitro Fertilization- CSC (Choline Substituted Cryopreservation) Thawing Medium, Product Number ART-8018. The recall is due to a labeling error where the products contain an international package insert rather than the correct USA package insert.
The affected lots are Lot no 16140184 (expires April 2017) and Lot no 15430149 (expires Oct. 2016). The products were distributed nationwide to California, Georgia, and New York. This product is intended for the thawing of embryos frozen with ART-8017, CSC Freezing Medium.
The FDA has classified this recall as Class III, indicating that use of or exposure to the violative product is not likely to cause adverse health consequences. No specific instructions for consumers are provided in the source text, but the issue is limited to the documentation included with the product.
The recalled product
- 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…
- Manufacturer
- CooperSurgical, Inc.
- Hazard
- Affected units
- 4
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot no 16140184 expires April 2017 Lot no 15430149 expires Oct. 2016
Distribution
Part of a larger recall action
This product is one of 2 recalled by CooperSurgical, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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