Medline convenience kits recalled due to weak packaging seals
Medline Industries is recalling 116 sterile convenience kits with Model Number DYNJ907733B due to potential weak seals on breather pouches. Compromised seals may affect product sterility during storage and distribution.
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 FDA Class II recall involves a packaging integrity defect affecting sterile medical kits. Although no illnesses or injuries have been reported, weak seals on breather pouches create a risk-of-harm scenario by potentially compromising product sterility, which could lead to infection if non-sterile supplies are used in medical procedures.
Plain-English summary
Medline Industries, LP is recalling the MINOR BASIN -SMH convenience kit, Model Number DYNJ907733B. The recall affects 116 units of these sterile medical convenience kits used for various procedures.
The reason for the recall is a potential for open or weak seals on the breather pouches used to package these sterile convenience kits. Breather pouches are designed to maintain product sterility during storage and distribution. When seals are compromised, non-sterile conditions may compromise the contents.
The affected kits were distributed worldwide, including the United States (nationwide), Canada, Mexico, Panama, and the U.S. Virgin Islands. The specific lot number involved is 24KBJ999, with UDI-DI numbers 10195327671730 (each) and 40195327671731 (case).
The recalled product
- Product
- Medline Convenience kits used for various procedures: 1) MINOR BASIN -SMH, Model Number: DYNJ907733B
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- seal-failure
- 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 (4)
- 1) DYNJ907733B
- UDI-DI: 10195327671730(each)
- 40195327671731(case)
- Lot Number: 24KBJ999
Distribution
Distributed nationwide across the United States.
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