Medline IV Start Kits Recalled for Potential Sterility Breach
Medline is recalling 22,736 IV start kits due to packaging defects that may compromise sterility, posing a risk of microbial contamination.
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 is classified as FDA Class II, and the source text describes potential for serious infection and hospitalization without reporting specific confirmed illnesses or deaths, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medline Industries, LP is recalling 22,736 IV start kits and blood culture kits distributed nationwide. The affected products include various models such as the IV Start Kit Lab Draw-SH, IV Start Kit, and IV Blood Culture Kit. The recall is due to a potential breach of sterility in the packaging, specifically caused by wrinkles in the paper lidding that may extend to the seal area.
If the sterile barrier is compromised, patients and users may be exposed to microbial contamination. Potential health consequences range from no injury to localized infection or more serious infections requiring medical treatment, antimicrobial therapy, or hospitalization. In rare cases, severe infection could become life-threatening, particularly for critically ill or immunocompromised patients.
Healthcare facilities and users should check their inventory for the specific model numbers and lot numbers listed in the official recall notice. If the products are found, they should be removed from use and returned to Medline or the distributor for credit or replacement.
The recalled product
- Product
- Medline Convenience Kits: 1) IV START KIT LAB DRAW-SH, Model Number: CDS860014P; 2) IV START KIT, Model Number: DYKM1000B; 3) KIT, I V START NSK, Model Number: DYKM2187; 4) KIT, I V START NSK, Model Number: DYKM2187A; 5) IV BLOOD CULTURE KIT, Model Number: DYNDH1909A…
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — IV Start Kits
- Affected units
- 22,736
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 (20)
- 1) CDS860014P
- UDI-DI: 10888277797819(each)
- 40888277797810(case)
- Lot Number: 25DBN710
- 2) CDS860014P
- Lot Number: 24BBH722
- 3) CDS860014P
- Lot Number: 24CBV460
- 4) CDS860014P
- Lot Number: 24EBR549
- 5) CDS860014P
- Lot Number: 24GBH769
- 6) CDS860014P
- Lot Number: 23KBN939
- 7) CDS860014P
- Lot Number: 23LBT913
- 8) DYKM1000B
- UDI-DI: 10889942508143(each)
- 40889942508144(case)
- Lot Number: 24AMB256
Distribution
Distributed nationwide across the United States.
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