Atlas FDA

Medline AMBULATORY MINI PACK, REF DYNJ82579; medical procedure convenience kit

FDA device recall Z-0172-2025 · posted 2024-10-23 · Open, Classified

Recall details

Recalling firm
MEDLINE INDUSTRIES, LP - Northfield
Reason for recall
It has been determined that certain Convenience kits that were packaged in breather pouch lot 323080002 may result in the potential of using non-sterile product if the vendor seal of the pouch is opened/unsealed.
Action taken
Medline issued a MEDICAL DEVICE RECALL notice to its consignees on 09/05/2024 via email and USPS. The notice explained the issue, hazard, and requested the destruction of the affected product. Distributors were directed to notify their consignees.
Root cause
Under Investigation by firm
Status
Open, Classified
Product code
NSB
Quantity affected
144 units
Distribution
Worldwide distribution - US Nationwide and the countries of Canada, Panama.
Date initiated
2024-09-04
Date posted
2024-10-23
Location
Northfield, IL

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