Cardinal Health Recalls Presource Convenience Kits Due to Seal Defects
Cardinal Health 200, LLC is recalling Presource Convenience Kits because applicator packaging may have open or incomplete seals, posing a risk of infection.
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: The recall is classified as FDA Class II and involves a risk of infection (localized or systemic) from potentially contaminated applicators, which fits the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Cardinal Health 200, LLC is voluntarily recalling 9,480 Presource Convenience Kits (Catalog Numbers PVMHIVMHD, PVMHIVM14, and PVMHIVM15). The recall is due to a defect where the packaging of the applicators contained in the kits may exhibit an open or incomplete seal.
The use of a potentially contaminated applicator could result in no patient harm, or it may lead to localized skin or soft tissue infection. In less common cases, systemic infection or other infectious complications may occur. The affected kits were distributed nationwide in the states of Florida, Kentucky, Missouri, North Carolina, Ohio, and Texas.
Healthcare facilities and consumers should stop using the affected kits and contact Cardinal Health 200, LLC for further instructions or a return. The recall is classified as FDA Class II, indicating a reasonable probability of temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Presource Convenience Kits: 1) KIT, USGPIV , Catalog Number: PVMHIVMHD; 2) KIT, USGPIV , Catalog Number: PVMHIVM14; 3) KIT, USGPIV , Catalog Number: PVMHIVM15
- Manufacturer
- Cardinal Health 200, LLC
- Category
- Medical Device — IV Therapy Kits
- Affected units
- 9,480
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) PVMHIVMHD
- UDI-DI: 10197106488959(each)
- 50197106488957(case)
- Lot Number: 20
- 2) PVMHIVMHD
- Lot Number: 5126398
- 3) PVMHIVMHD
- 4) PVMHIVMHD
- Lot Number: 5129488
- 5) PVMHIVMHD
- Lot Number: 5181074
- 6) PVMHIVMHD
- 7) PVMHIVMHD
- Lot Number: 5182660
- 8) PVMHIVMHD
- Lot Number: 5188103
- 9) PVMHIVMHD
- 10) PVMHIVMHD
- 11) PVMHIVMHD
- 12) PVMHIVMHD
Distribution
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