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U.S. Department of Health and Human Services

Class 2 Device Recall Origio Sperm Wash Medium

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 Class 2 Device Recall Origio Sperm Wash Mediumsee related information
Date Initiated by FirmFebruary 16, 2024
Date PostedSeptember 26, 2024
Recall Status1 Open3, Classified
Recall NumberZ-3298-2024
Recall Event ID 95246
510(K)NumberK153267 
Product Classification Media, reproductive - Product Code MQL
ProductOrigio Sperm Wash Medium Pack of Five 60ml bottles - Intended for washing of spermatozoa. Part Number: 84055060D
Code Information UDI: 20888937816918 Lot 230922-018009 Expiration date: 20 September 2024
FEI Number 1216677
Recalling Firm/
Manufacturer		 CooperSurgical, Inc.
95 Corporate Dr
Trumbull CT 06611-1350
For Additional Information ContactSAME
203-601-5200
Manufacturer Reason
for Recall		Low concentration of sodium pyruvate in the wash could compromise gamete development
FDA Determined
Cause 2		Under Investigation by firm
ActionCooperSurgical 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 recall@coopersurgical.com.
Quantity in Commerce770 units
DistributionWorldwide distribution - US Nationwide.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = MQL
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