Medline surgical convenience kits labeled as: 1) NEURO-SPINE BASIN PACK, Medline Product Number/S
Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking 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
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking during use.
The recalled product
- Product
- Medline surgical convenience kits labeled as: 1) NEURO-SPINE BASIN PACK, Medline Product Number/SKU DYNJ80055A; 2) AV SHUNT PACK-LF, Medline Product Number/SKU DYNJ24528M.
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Devices
- Affected units
- 1,900
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 product number/SKU DYNJ80055A
- UDI/DI 10198459093425 (each) 40198459093426 (case)
- Lot number 26BBC545
- Lot number 26ABM193
- Lot number 25LBD334
- Lot number 25JBL305
- Lot number 25IBF209
- Lot number 25HBI041
- Lot number 25FBF808
- Lot number 25EBO692
- Lot number 25DBG912
- Lot number 25BBS302
- Lot number 25ABN459
- Lot number 24LBQ417
- Lot number 24KBL387
- Lot number 24KBB074
- Lot number 24IBI827
- Lot number 24HBL301
- Medline product number/SKU DYNJ24528M
- UDI/DI 10193489678222 (each) 40193489678223 (case)
Distribution
Distributed nationwide across the United States.
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