Medline Blood Draw and Phlebotomy Kits Recalled for Sterility Breach
Medline is recalling approximately 996,692 blood draw and phlebotomy kits due to potential sterility breaches in the packaging. The defect may expose patients to 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, and the source text explicitly states that potential health consequences include hospitalization and life-threatening infections, meeting the criteria for a Severe rating.
Plain-English summary
Medline Industries, LP is recalling approximately 996,692 units of various blood draw, phlebotomy, and blood culture kits. The affected products include specific catalog numbers such as DYLAB1081, DYNDB3005D, and DYNDH1194A, among others. These kits were distributed nationwide in the United States.
The recall is due to a potential breach of sterility in the packaging of the BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators contained within the kits. Wrinkles in the paper lidding may extend to the seal area, compromising the sterile barrier. If the sterile barrier is compromised, patients and users may be exposed to microbial contamination.
Potential health consequences include no injury, localized infection, or more serious infections requiring medical treatment, antimicrobial therapy, procedural intervention, or hospitalization. In rare cases, particularly for critically ill or immunocompromised patients, severe infection could become life-threatening. Healthcare facilities should stop using the affected kits and contact Medline for instructions on return or disposal.
The recalled product
- Product
- Medline Convenience Kits: 1) BLOOD DRAW KIT, Catalog Number: DYLAB1081; 2) WHOLE BLOOD PHLEBOTOMY KIT, Catalog Number: DYNDB3005D; 3) QP KIT, Catalog Number: DYNDB3005F; 4) DOUBLE RED CELL PHLEBOTOMY KIT, Catalog Number: DYNDB3006C; 5) PLATELET PHLEBOTOMY KIT, Catalog…
- Manufacturer
- Medline Industries, LP
- Category
- Medical Device — Phlebotomy Kits
- Affected units
- 996,692
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) DYLAB1081
- UDI-DI: 10198459199608(each)
- 40198459199609(case)
- Lot Number: 25CMC514
- 2) DYNDB3005D
- UDI-DI: 10195327038700(each)
- 40195327038701(case)
- Lot Number: 24CBG614
- 3) DYNDB3005D
- Lot Number: 24CBT912
- 4) DYNDB3005D
- Lot Number: 23HBH298
- 5) DYNDB3005D
- Lot Number: 23JBN521
- 6) DYNDB3005D
- Lot Number: 23KBT270
- 7) DYNDB3005F
- UDI-DI: 10198459025068(each)
- 40198459025069(case)
- Lot Number: 25BBD241
Distribution
Distributed nationwide across the United States.
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