Z-0111-2023Class II

Medicina Oral Tip Syringe 2.5ml Code: OT25

Name: Z-0111-2023 Medicina Oral Tip Syringe 2.5ml Code: OT25
Creator: Medicina Uk Ltd
Published: 2022-07-04
License: https://open.fda.gov/license/

Medicina Ltd / initiated 2022-07-04 / Open, Classified / root cause: manufacturing process

FDA source

Medicina Uk Ltd began a recall of Medicina Oral Tip Syringe 2.5ml Code: OT25 on 2022-07-04. FDA classified it as Class II and gives the reason as "Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropylene) and does not meet raw material specification". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0111-2023
Classification: Class II
Status: Open, Classified
Initiated: 2022-07-04
Posted: 2022-10-20
Recalling firm: Medicina Ltd
Product: Medicina Oral Tip Syringe 2.5ml Code: OT25
Product code: KYW Container, Liquid Medication, Graduated
Reason for recall: Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropylene) and does not meet raw material specification
Root cause tag: manufacturing process
FDA 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: [email protected] Tel: 01204 695050
Quantity in commerce: 20 boxes (2000 syringes)
Distribution: Nationwide
Product codes and lots: UDI-DI:(01)05060278503431 Batch number: HM19026, HM19165, HM20019, HM20064, HM21061

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0111-2023
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0107-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-10-26	2022-10-20
Z-0108-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-10-26	2022-10-20
Z-0109-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-10-26	2022-10-20
Z-0110-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-10-26	2022-10-20
Z-0111-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-10-26	2022-10-20
Z-0112-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-10-26	2022-10-20
Z-0113-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-10-26	2022-10-20
Z-0114-2023	Class II	Ongoing	Voluntary: Firm initiated	2022-10-26	2022-10-20

Product code KYW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)