Reusable Oral Syringe Recalled for Unapproved Plunger Material
Medicina UK Ltd is recalling Reusable Oral Syringes because plungers were manufactured from unapproved polyethylene instead of the specified polypropylene material.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II medical device recall for material specification non-compliance affecting a product used for oral drug administration in vulnerable populations. While no injuries have been reported, improper plunger material creates a documented risk of device failure and potential harm.
Plain-English summary
Medicina UK Ltd is recalling Medicina Reusable Oral Syringes (5ml, Code OTH05) distributed nationwide. The plunger component was manufactured with polyethylene instead of the specified polypropylene material and does not meet raw material specifications.
Proper plunger material is critical for syringe function and safety. The use of an unapproved material may compromise plunger performance, potentially affecting accurate medication or fluid delivery, particularly for vulnerable populations such as children and elderly patients who depend on oral syringes.
The recalled product includes 26 boxes containing 2600 syringes distributed nationwide. Affected units are identified by batch numbers HM18043, HM20020, and HM21055, and the UDI-DI (01)05056115403491(17)260700(10). Consumers or healthcare facilities in possession of this product should discontinue use and contact the manufacturer for further instructions.
The recalled product
- Product
- Medicina Reusable Oral syringe 5ml Code: OTH05
- Manufacturer
- Medicina Uk Ltd
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- HM20020
- HM21055
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 8 recalled by Medicina Uk Ltd under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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