Medicina Oral Tip Syringe recalled for unapproved plunger material
Medicina Uk Ltd is recalling Medicina Oral Tip Syringe 2.5ml nationwide because the plunger component was manufactured with polyethylene instead of the approved 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: This is a medical device recall involving a material specification defect in a critical component (plunger). Although no injuries or illnesses have been reported, the use of unapproved material in a syringe plunger creates potential risk of harm. This fits the rubric criterion for high-risk products where injury has not yet been reported.
Plain-English summary
Medicina Uk Ltd is recalling the Medicina Oral Tip Syringe 2.5ml Code: OT25 because the plunger component was manufactured with polyethylene, which does not meet the required raw material specification of polypropylene.
The affected syringes were distributed nationwide. The recall includes 20 boxes (2000 syringes) with the following batch numbers: HM19026, HM19165, HM20019, HM20064, and HM21061. The product has a UDI-DI of (01)05060278503431.
Use of syringes with the incorrect plunger material may affect the proper functioning and safety of the device. Consumers who have this product should stop using it and contact the manufacturer or their healthcare provider for guidance on replacements.
The recalled product
- Product
- Medicina Oral Tip Syringe 2.5ml Code: OT25
- 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 (5)
- UDI-DI:(01)05060278503431 Batch number: HM19026
- HM19165
- HM20019
- HM20064
- HM21061
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.
See all 8 products in this recall →Related recalls
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