Medline Ambulatory Mini Pack medical kits may be non-sterile if seal compromised
Medline is recalling certain Ambulatory Mini Pack convenience kits from lot 23LBO804 because they may be non-sterile if the vendor seal on the breather pouch is opened or unsealed.
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: FDA Class II medical device with potential sterility risk if the vendor seal is compromised. No illnesses or injuries have been reported. This is a risk-of-harm product where injury has not yet been reported, meeting Score 3 criteria.
Plain-English summary
Medline Industries, LP is recalling certain Ambulatory Mini Pack medical procedure convenience kits (REF DYNJ82579, lot number 23LBO804) due to a vendor seal integrity issue in the breather pouches (lot 323080002).
The convenience kits packaged in the affected breather pouches may result in the potential of using non-sterile product if the vendor seal of the pouch is opened or unsealed. Sterility is critical for medical procedure kits, and non-sterile products pose a potential risk.
The affected kits were distributed worldwide, including the United States, Canada, and Panama, with 144 units involved in this recall. The product UDI/DI identifiers are 40195327198153 (individual) and 10195327198152 (case).
Users should inspect affected lots (23LBO804 for the kit and 323080002 for the breather pouch) and verify the vendor seal is intact before use. Contact Medline Industries for further guidance on affected products.
The recalled product
- Product
- Medline AMBULATORY MINI PACK, REF DYNJ82579; medical procedure convenience kit
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- non-sterile
- seal-integrity
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 (3)
- UDI/DI 40195327198153 (each)
- 10195327198152 (case)
- Lot Numbers: 23LBO804
Distribution
Distributed nationwide across the United States.
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