Medline Recalls IV Convenience Kits for Potential Seal Defects
Medline is recalling 84 IV PACK SOUTH convenience kits due to potential weaknesses in breather pouch seals that may compromise sterility. The affected kits were distributed worldwide including the US, Canada, Mexico, Panama, and the Virgin Islands.
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 recall for potential seal integrity defects on sterile medical device kits. While no illnesses or injuries are reported in the source, seal failure on sterile packaging represents a significant risk of contamination, matching the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medline Industries is recalling 84 IV PACK SOUTH convenience kits (Model DYNJ88422, Lot 24KBD426) due to potential open or weak seals on the breather pouches used in their packaging. These seals are essential for maintaining sterility during storage and transport.
The affected kits were distributed worldwide, including throughout the United States and to Canada, Mexico, Panama, and the Virgin Islands. Healthcare facilities and providers who received these kits should discontinue use and follow Medline's instructions for return or replacement.
Patients or healthcare workers should contact their healthcare provider if they have concerns about IV kits they may have used from this lot. The FDA has classified this as a Class II recall.
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
- contamination-risk
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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