FDA Medical Device Recalls (openFDA)
Medicina Uk Ltd: Medicina ENFit 1ml Reusable Low Dose Enteral Syringe Code: LHE01LD
- Recall number
- Z-0107-2023
- Recalling firm
- Medicina Uk Ltd
- Product
- Medicina ENFit 1ml Reusable Low Dose Enteral Syringe Code: LHE01LD
- Status
- Open, Classified
- Initiated
- 2022-07-04
- Posted
- 2022-10-20
- Terminated
- not on file
- Reason
- Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropylene) and does not meet raw material specification
- Root cause
- 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
- 9 boxes (900 syringes)
- Distribution
- Nationwide
- Lot, serial or model codes
- UDI-DI: (01)05060278508146 Batch number: HM17121, HM18051, HM18080, HM18120, HM18141, HM19007, HM19016, HM19059, HM19083, HM19130, HM19144, HM20005, HM20054, HM21044, HM22018
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KYW
- Firm FEI
- 3008432385
- Firm city
- Bolton
- Firm state
- not on file
- Firm country
- United Kingdom
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28