Perfusion syringes recalled over tip caps that failed biocompatibility testing
Medline is recalling 15 Medline Perfusion Syringes because they contain BD Luer Tip Caps from trays that failed routine biocompatibility testing.
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: Scored 3 under the risk-of-harm criterion: the firm names potential outcomes including sensitization and acute systemic toxicity, and no injuries are reported.
Plain-English summary
The Medline Perfusion Syringe, REF DYNJ39223C, is being recalled by Medline Industries, LP as part of a recall of specific Medline kits containing BD Luer Tip Caps.
BD has issued a recall of its Luer Tip Caps after confirming through internal testing that certain BD Luer Tip Cap trays failed routine biocompatibility testing. Medline states that although the tip cap covers a small surface area of the syringe and does not come into direct contact with patients, there is the potential that the failure of a biocompatibility test may have varying consequences ranging from no harm or clinical impact to potential for sensitization, irritation, pyrogenicity, acute systemic toxicity or hemolysis, depending on the nature and duration of contact with the syringe.
The record lists 15 units carrying UDI/DI 10193489621532 for each and 40193489621533 for the case, from lot 25FMJ081. Distribution was nationwide in the United States, in California. The FDA has classified the action as Class II.
Facilities should quarantine the affected lot and follow Medline's instructions.
The recalled product
- Product
- MEDLINE PERFUSION SYRINGE, REF: DYNJ39223C
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Syringe
- Affected units
- 15
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)
- UDI/DI 10193489621532 (each) 40193489621533 (case)
- Lot Number 25FMJ081
Distribution
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