[pending] Medline Convenience kits used for various procedures: 1) LARGE BIOPSY PACK NTX, Model Number: DYNJ6
Pending LLM rewrite. Source: FDA_DEVICE Z-1594-2025.
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) LARGE BIOPSY PACK NTX, Model Number: DYNJ68393A; 2) SOFT TISSUE BIOPSY PACK, Model Number: DYNJ81441B; 3) BILAT TESTICULAR SPERM EXTRACT, Model Number: DYNJ68303; 4) PROCEDURE MINEURE BJC-LF, Model Number: DYNJ41678B
- 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 (20)
- 1) DYNJ68393A
- UDI-DI: 10193489939996(each)
- 40193489939997(case)
- Lot Number: 24IBP745
- 2) DYNJ81441B
- UDI-DI: 10198459111105(each)
- 40198459111106(case)
- Lot Number: 24JBB770
- 3) DYNJ68303
- UDI-DI: 10193489821529(each)
- 40193489821520(case)
- Lot Number: 24JBU406
- 4) DYNJ41678B
- UDI-DI: 10198459124129(each)
- 40198459124120(case)
- Lot Number: 24JBW438
- 5) DYNJ41678B
- Lot Number: 24JBW452
- 6) DYNJ55215G
- UDI-DI: 10193489925555(each)
Distribution
Distributed nationwide across the United States.
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