Medline Industries IV Administration and Extension Sets Recalled Due to Potential Leaks
Medline Industries, LP is recalling various IV administration and extension sets because male luer connectors may leak, crack, or break during use.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: The recall involves medical devices where failure could lead to high-risk complications like infection or air embolism, though no injuries have been reported.
Plain-English summary
Medline Industries, LP is recalling several models of IV Administration and Extension Sets. The recall involves approximately 926,227 units distributed in the United States and the Bahamas.
Under certain conditions involving mechanical forces and exposure to specific chemicals, the male luer connectors on these sets may leak, crack, or break during use. This failure could lead to serious complications, including infection, air embolism, blood loss, medication underdosage, or delays in patient treatment.
Affected products include various model numbers such as DYNDTB0529, DYNDTB1029, DYNDTB1516, and others listed in the official notice. All lot numbers are included in this recall.
The recalled product
- Product
- Medline Industries IV Administration and Extension Sets: 1) DBD-IV ADMIN SET,60DRP,1NEEDLE-FREE VALV, Model Number: DYNDTB0529; 2) IV ADMIN SET, 10DRP, 1NF, 92, Model Number: DYNDTB1029; 3) DBD-IVEXTSET2.4ML2 NEEDLE-FREEVLVE,35, Model Number: DYNDTB1516; 4) DBD-IV ADMIN…
- Manufacturer
- Medline Industries, LP
- Affected units
- 926,227
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 (20)
- 1) DYNDTB0529
- UDI-DI: 10197344105663(each)
- 20197344105660(case)
- Lot Number: All Lot Numbers
- 2) DYNDTB1029
- UDI-DI: 10197344076956(each)
- 20197344076953(case)
- 3) DYNDTB1516
- UDI-DI: 10197344105687(each)
- 20197344105684(case)
- 4) DYNDTB1530
- UDI-DI: 10197344105694(each)
- 20197344105691(case)
- 5) DYNDTB1539
- UDI-DI: 10197344008254(each)
- 20197344008251(case)
- 6) DYNDTB1545
- UDI-DI: 10197344098644(each)
- 20197344098641(case)
- 7) DYNDTB2045
Distribution
Distributed nationwide across the United States.
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