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Origio Sperm Wash Medium Pack of Ten 10ml bottles - Intended for washing of spermatozoa Part N...

FDA Recall #Z-3296-2024 — Class II — February 16, 2024

Recall #Z-3296-2024 Date: February 16, 2024 Classification: Class II Status: Ongoing

Product Description

Origio Sperm Wash Medium Pack of Ten 10ml bottles - Intended for washing of spermatozoa Part Number: 84051010A

Reason for Recall

Low concentration of sodium pyruvate in the wash could compromise gamete development

Recalling Firm

CooperSurgical, Inc. — Trumbull, CT

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

980 units

Distribution

Worldwide distribution - US Nationwide.

Code Information

UDI: 20888937816536 Lot 230922-018006 Expiration date: 20 September 2024

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated

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