CooperSurgical embryo culture medium product substitution recall
CooperSurgical is recalling Global Total LP embryo culture medium after discovering affected units may contain a different medium lacking the required protein source for embryo development.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is a risk-of-harm product where injury has not yet been reported. The product mix-up results in an inadequate formulation lacking essential components required for its intended use, with no confirmed adverse outcomes reported to date.
Plain-English summary
CooperSurgical, Inc. is recalling Global Total LP single step medium (60mL, bicarbonate-buffered) used for embryo culture and transfer. The recall affects 190 units with lot number 221118-010694 (UDI-DI: 00815965020433).
The affected product may contain a medium other than Global Total LP single step medium, which does not contain the protein source required for embryo culture and development. This represents a product mix-up where the wrong medium may have been distributed in packages labeled as Global Total LP.
The product was distributed worldwide, including in the United States in the states of New York and Utah, as well as internationally in Argentina, Belgium, Bulgaria, Ecuador, France, Germany, Hong Kong, Italy, Malaysia, Mexico, Peru, Singapore, Spain, Switzerland, Thailand, Turkey, and the United Kingdom.
Patients and healthcare providers who have this product should contact CooperSurgical or their healthcare provider regarding potential impact on any embryo culture procedures.
The recalled product
- Product
- Global Total LP single step medium, 60mL, bicarbonate-buffered media for D1-5 embryo culture and transfer, Reference Number H5GT-060
- Manufacturer
- CooperSurgical, Inc.
- Affected units
- 190
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 (2)
- UDI-DI: 00815965020433
- LOT 221118-010694
Distribution
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