Medline Blood Culture Kits Recalled Due to Incomplete Applicator Seals
Medline is recalling blood culture kits containing BD ChloraPrep applicators with open or incomplete seals. The defect may allow contamination, posing a risk of 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 systemic infection from a contaminated medical device, which is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Medline Industries, LP is recalling specific lots of Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators. The recall involves 222,653 units distributed nationwide in the United States. The affected products include various adult and pediatric blood culture kits and blood draw kits.
The recall was initiated because the packaging of the applicators may exhibit an open or incomplete seal. This defect could allow the applicators to become contaminated. Using a potentially contaminated applicator may lead to localized skin or soft tissue infection, or systemic infection and infectious complications.
Healthcare facilities and consumers should check their inventory for the specific lot numbers listed in the official recall notice. If the product is found, it should be removed from use and returned to Medline Industries, LP or the distributor for a refund or replacement.
The recalled product
- Product
- Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators ADULT BLOOD CULTURE KIT DYNDH1444D BLOOD CULTR KT DIVRSN DEVICE DYNDH1866 BLOOD CULTURE KIT DYNDH1462B DYNDH1622C DYNDH1622D DYNDH1622F DYNDH1715B DYNDH2028 DYNDH2048 BLOOD…
- Manufacturer
- Medline Industries, LP
- Hazard
- Affected units
- 222,653
Distribution
Distributed nationwide across the United States.
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