[pending] Medline Industries IV Administration and Extension Sets: 1) DBD-IV ADMIN SET,60DRP,1NEEDLE-FREE VAL
Pending LLM rewrite. Source: FDA_DEVICE Z-1366-2026.
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: Pending LLM scoring against the rubric.
Plain-English summary
Under circumstances involving exposure to particular chemicals and mechanical forces, the male luer connectors for the specified IV Administration and Extension sets may leak, crack, and/or break during use, which may result in a delay in patient treatment, blood loss, infection, an air embolism, and/or underdosage of medication.
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 SE
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Devices
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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