Medline IV TEAM PICC Kits Recalled Due to Potential Non-Sterile Product
Medline IV TEAM PICC medical procedure kits may contain non-sterile product if the breather pouch vendor seal has been opened. The recall affects 120 units distributed worldwide including the US, Canada, and Panama.
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 involving a potential sterility issue on a medical device used in invasive procedures. No illnesses or injuries have been reported in the source text. The hazard presents a risk-of-harm scenario where injury has not yet been reported, which aligns with the rubric criterion for High severity.
Plain-English summary
Medline Industries, LP has recalled Medline IV TEAM PICC convenience kits (REF DYNJ48222, lot number 23LBS908) that were packaged in breather pouch lot 323080002. A total of 120 units were distributed.
The recalled kits may result in the potential of using non-sterile product if the vendor seal of the breather pouch has been opened or unsealed.
The affected kits were distributed worldwide, including throughout the United States, Canada, and Panama.
Individuals or healthcare facilities with these kits should verify the lot number and contact Medline Industries, LP for guidance.
The recalled product
- Product
- Medline IV TEAM PICC, REF DYNJ48222; medical procedure convenience kit
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device — IV Line Kit
- Hazard
- Affected units
- 120
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 40888277567925 (each)
- 10888277567924 (case)
- Lot Numbers: 23LBS908
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 33 recalled by MEDLINE INDUSTRIES, LP - Northfield under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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