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Origio Sperm Wash Medium Pack of Five 60ml bottles -… recallZ-3298-2024 · CooperSurgical, Inc. · initiated Feb 16, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from CooperSurgical, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Under Investigation by firm

What the company is doing

CooperSurgical issued Urgent: Voluntary Medical Device Field Safety Notice on 2/16/24 via UPS Next Day Air via third party Sedgewick. Letter states reason for recall, health risk and action to take: 1) Inspect your inventory, quarantine any affected product, and immediately stop using the product. 2) Complete the appropriate version of the attached form (Customer Acknowledgement Form or Distributor Acknowledgement Form). Once completed, return the form to CooperSurgical as indicated at the top of the form. Note: Even if you do not have any affected product in your inventory ( or have not distributed any affected product to customers), please complete and return the enclosed form so that we may document receipt of this FSN. When the completed form is received by CooperSurgical, arrangements will be made for the return of any affected product at no additional cost to you. Credit will be applied to your account for product returned under this action. CooperSurgical is committed to high-quality, safe, and effective products. This corrective action has been initiated to ensure this failure mode does not reoccur and future potential patient harms can be avoided. If you have any questions, please feel free to reach us at +1 203-601-5200 ext. 3300 or [email protected].

Recall details

Recall number
Z-3298-2024
Status
Open, Classified
Initiated by the company
Feb 16, 2024
Posted by the FDA
Sep 26, 2024
Recalling firm
CooperSurgical, Inc.
Quantity
770 units
Product code
MQL
FDA submissions
K153267
Distribution
Worldwide distribution - US Nationwide.

Product description

Origio Sperm Wash Medium Pack of Five 60ml bottles - Intended for washing of spermatozoa. Part Number: 84055060D

Code information (models, lots, serial numbers)

UDI: 20888937816918 Lot 230922-018009 Expiration date: 20 September 2024

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 95246).

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page