Medline IV Start Kits Recalled Due to Potential Seal Defects
Medline is recalling IV start kits containing BD ChloraPrep applicators with potentially open or incomplete seals, which may lead to infection.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: The recall involves a risk-of-harm product where the hazard is potential infection due to contamination, but no injuries or illnesses have been reported in the source text.
Plain-English summary
Medline Industries, LP is recalling specific lots of Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators. The affected products include IV Start Kits and Ultrasound Guided PIV Start Kits. This is a downstream recall initiated because the manufacturer of the BD ChloraPrep applicators recalled specific lots due to packaging defects.
The affected product may exhibit an open or incomplete seal on the packaging of the applicator. The use of a potentially contaminated applicator may lead to localized skin or soft tissue infection, or systemic infection or infectious complications. A total of 222,653 units were distributed nationwide in the US.
Healthcare facilities and consumers should check their inventory for the specific product codes and lot numbers listed in the recall notice. If the product is found, it should be removed from use and returned to the supplier or manufacturer according to the recall instructions.
The recalled product
- Product
- Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators IV START KIT LAB DRAW-SH CDS860014Q IV START KIT DYKM1000B IV START KIT LAB DRAW-SH CDS860014P ULTRASOUND GUIDED PIV START KI DYNDV2684
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — IV Start Kits
- Affected units
- 222,653
Distribution
Distributed nationwide across the United States.
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