Medicina Oral Tip Syringe 1ml Code: OT01
- Company
- Medicina Uk Ltd
- Recall Initiated
- July 4, 2022
- Posted
- October 20, 2022
- Recall Number
- Z-0110-2023
- Quantity
- 29 boxes (2900 syringes)
Reason for Recall
Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropylene) and does not meet raw material specification
Distribution
Nationwide
Lot / Code Info
UDI-DI: (01)05060278503424 Batch number: HM18147, HM19012, HM19025, HM19088, HM19164, HM20063 HM21015, HM21072
Root Cause
Nonconforming Material/Component
Action Taken
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