Medline Medical Procedure Convenience Kits Recalled for Potential Sterility Issue
Medline is recalling 312 medical procedure convenience kits due to potential sterility issues if the breather pouch seal is opened or damaged. The affected kits were distributed in the US, Canada, and Panama.
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: This is an FDA Class II recall of medical procedure kits with a potential sterility hazard. No illnesses or injuries have been reported. Per the severity rubric, risk-of-harm products without reported injury are classified as High (score 3).
Plain-English summary
Medline Industries, LP is recalling 312 medical procedure convenience kits. The affected products are the Medline SET UP PACK (Reference DYNJ36320A, Lot 24ABC836) and ANGIOGRAM WRO-LF (Reference DYNJ41876B, Lot 23LBM850). The kits were distributed in the United States, Canada, and Panama.
The kits were packaged in breather pouches with lot number 323080002. The FDA determined that if the vendor seal on these pouches is opened or unsealed, the contents could become non-sterile, potentially exposing patients to contaminated medical equipment.
The recalled product
- Product
- Medline brand, medical procedure convenience kits, labeled as: a) SET UP PACK, REF DYNJ36320A; b) ANGIOGRAM WRO-LF, REF DYNJ41876B
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — Procedure Kit
- Hazard
- sterility-risk
- contamination
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 (8)
- a) DYNJ36320A
- UDI/DI 40889942245230 (each)
- 10889942245239 (case)
- Lot Numbers: 24ABC836
- b) DYNJ41876B
- UDI/DI 40193489563086 (each)
- 10193489563085 (case)
- Lot Numbers: 23LBM850
Distribution
Distributed nationwide across the United States.
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