[pending] MEDLINE Medical Procedure Kits labeled as: 1) CV DRAPING/BASIN, Medline Kit Number/SKU DYNJ908483
Pending LLM rewrite. Source: FDA_DEVICE Z-2496-2026.
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
During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surface finish, instances where the catheter connector detached prematurely from the catheter funnel, and limited cases where the catheter outer diameter did not meet specification.
The recalled product
- Product
- MEDLINE Medical Procedure Kits labeled as: 1) CV DRAPING/BASIN, Medline Kit Number/SKU DYNJ908483A; 2) CV DRAPING/BASIN, Medline Kit Number/SKU DYNJ908483B; 3) CV DRAPING/BASIN, Medline Kit Number/SKU DYNJ908483C; 4) CV DRAPING/BASIN 2PART PACK, Medline Kit Number/SKU DY
- 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)
- Medline Kit Number/SKU DYNJ908483A: UDI/DI 10195327191887
- (each) 40195327191888
- (case)
- Lot Number 22HMA818
- Lot Number 22GMG188
- Medline Kit Number/SKU DYNJ908483B: UDI/DI 10195327287764
- (each) 40195327287765
- Lot Number 23FMB021
- Lot Number 23CMB395
- Lot Number 23BMF105
- Medline Kit Number/SKU DYNJ908483C: UDI/DI 10195327432119
- (each) 40195327432110
- Lot Number 25BMG115
- Lot Number 24KMG981
- Lot Number 24KMG043
- Lot Number 24KME988
- Lot Number 24JMC883
- Lot Number 24HMG291
- Lot Number 24GMG957
- Lot Number 24GMC708
Distribution
Distributed nationwide across the United States.
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