Medline Convenience Kits Recalled for Potential Breather Pouch Seal Defects
Medline is recalling select IV convenience kits due to potential open or weak seals on breather pouches used for packaging. The defective seals may compromise sterility of the medical devices.
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 sterile medical device kits where a packaging defect (open/weak seals) presents a risk of harm—specifically compromised sterility—but no reported illnesses or injuries are stated in the source text. Per the rubric, risk-of-harm products where injury has not yet been reported score 3.
Plain-English summary
Medline Industries, LP is recalling select Medline Convenience kits, specifically IV PACK SOUTH (Model Number DYNJ88422, Lot Number 24KBD426), because of a potential for open or weak seals on the breather pouches used for packaging these sterile convenience kits.
Affected kits have been distributed worldwide, including the United States and Canada, Mexico, Panama, and the Virgin Islands. The recall involves 84 kits with the specified model and lot number.
Healthcare facilities and providers who have received these kits should discontinue use of the affected lot and contact Medline Industries for instructions on return or replacement. The weak or open seals may allow the sterile contents to be compromised.
The recalled product
- Product
- Medline Convenience kits used for various procedures: 1) IV PACK SOUTH, Model Number: DYNJ88422
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- seal-defect
- sterility-compromise
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) DYNJ88422
- UDI-DI: 10198459157042(each)
- 40198459157043(case)
- Lot Number: 24KBD426
Distribution
Distributed nationwide across the United States.
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