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U.S. Department of Health and Human Services

Class 2 Device Recall Medicina

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  Class 2 Device Recall Medicina see related information
Date Initiated by Firm July 04, 2022
Date Posted October 20, 2022
Recall Status1 Open3, Classified
Recall Number Z-0113-2023
Recall Event ID 90849
Product Classification Container, liquid medication, graduated - Product Code KYW
Product Medicina Reusable Oral syringe 5ml
Code: OTH05
Code Information UDI-DI: (01)05056115403491 (01)05056115403491(17)260700(10)HM21055 Batch number: HM18043, HM20020, HM21055
Recalling Firm/
Manufacturer		 Medicina Uk Ltd
Unit 2
Rivington View Business Park
Bolton United Kingdom
Manufacturer Reason
for Recall		 Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropylene) and does not meet raw material specification
FDA Determined
Cause 2		 Nonconforming Material/Component
Action Medicina Ltd issued Field Safety Corrective Action notice to the US Distributor 07/04/2022 via email. The US Distributor is conducting recall to the user level letter issued the week of July 25th via United States Postal Service. . Letter states reason for recall, health risk and action to take: Action to be taken - Please carefully read this Field Safety Notice and return the Acknowledgement Form - Please do not use any of the batches of product listed on this notice - If you have product to return, please complete the information on the Acknowledgement Form and our team will arrange the return for you - Please distribute throughout your organisations and to relevant personnel - If you have any questions or queries in relation to this notice, please contact us using the information below Contact information regarding FSN Shaista Patel QA/RA Administrator Unit 2, Rivington View Business Park, Station Road, Blackrod, Bolton BL6 5BN Email: quality.administrator@medicina.co.uk Tel: 01204 695050
Quantity in Commerce 26 boxes (2600 syringes)
Distribution Nationwide
Total Product Life Cycle TPLC 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.
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