FDAClass IIOctober 26, 2022

Medicina Reusable Oral syringe recall

Medicina Reusable Oral syringe 5ml Code: OTH05

Why was Medicina Reusable Oral syringe recalled?

Plunger component has been manufactured with an unapproved material (Polyethylene not Polypropylene) and does not meet raw material specification

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

UDI-DI: (01)05056115403491 (01)05056115403491(17)260700(10)HM21055 Batch number: HM18043, HM20020, HM21055

Product
Medicina Reusable Oral syringe 5ml Code: OTH05
Recalling firm
Medicina Uk Ltd
Quantity
26 boxes (2600 syringes)
Distribution
Nationwide
Recall date
October 26, 2022
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls