[pending] Medline Convenience kits used for various procedures: 1) NEURO PACK WRO-LF, Model Number: DYNJ41856
Pending LLM rewrite. Source: FDA_DEVICE Z-1610-2025.
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
There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
The recalled product
- Product
- Medline Convenience kits used for various procedures: 1) NEURO PACK WRO-LF, Model Number: DYNJ41856C; 2) STIM IMPLANT PACK, Model Number: DYNJ53032C; 3) WMC VP SHUNT PACK-LF, Model Number: DYNJ50629M; 4) SHUNT PACK, Model Number: DYNJ40040C; 5) STIM IMPLANT PACK, Model N
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- 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 (18)
- 1) DYNJ41856C
- UDI-DI: 10195327429010(each)
- 40195327429011(case)
- Lot Number: 24JBM711
- 2) DYNJ53032C
- UDI-DI: 10195327494094(each)
- 40195327494095(case)
- Lot Number: 24JBN788
- 3) DYNJ50629M
- UDI-DI: 10198459146985(each)
- 40198459146986(case)
- Lot Number: 24JBW674
- 4) DYNJ40040C
- UDI-DI: 10889942683970(each)
- 40889942683971(case)
- Lot Number: 24KBC507
- 5) DYNJ53032C
- Lot Number: 24KBC655
Distribution
Distributed nationwide across the United States.
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