Origio Sperm Wash Medium Recalled for Low Sodium Pyruvate Concentration
CooperSurgical is recalling Origio Sperm Wash Medium due to low sodium pyruvate concentration. The deficiency could compromise gamete development in assisted reproductive procedures.
What this means for you
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 an FDA Class II medical device recall with a theoretical risk-of-harm condition (low sodium pyruvate could compromise gamete development) and no reported illnesses or injuries. Per the severity rubric, risk-of-harm products where injury has not yet been reported receive a High (3) rating.
Plain-English summary
CooperSurgical, Inc. is recalling Origio Sperm Wash Medium, a medical device pack of five 60ml bottles (Part Number 84055060D) used to wash spermatozoa.
The recall was initiated due to a low concentration of sodium pyruvate in the wash. This low concentration could compromise gamete development.
This recall affects 770 units distributed worldwide, including throughout the United States. The affected lot is 230922-018009, with an expiration date of September 20, 2024. Users of the recalled product should contact CooperSurgical for appropriate follow-up instructions.
The recalled product
- Product
- Origio Sperm Wash Medium Pack of Five 60ml bottles - Intended for washing of spermatozoa. Part Number: 84055060D
- Manufacturer
- CooperSurgical, Inc.
- Hazard
- low-sodium-pyruvate
- gamete-compromise
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)
- UDI: 20888937816918 Lot 230922-018009 Expiration date: 20 September 2024
Distribution
Distributed nationwide across the United States.
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