Cardinal Health Recalls Presource Convenience Kits Due to Potential Seal Defects
Cardinal Health is recalling 17,503 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 involves a risk of infection (localized or systemic) from potentially contaminated medical devices, which fits the rubric for 'risk-of-harm products where injury has not yet been reported.'
Plain-English summary
Cardinal Health 200, LLC is recalling 17,503 units of Presource Convenience Kits, including Pre Op, NICU Admit, Pre Procedure, IV Supplies, Patient Admissions, C Section, and Vaginal Delivery kits. 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 a 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 check their inventory for the specific catalog numbers and lot numbers listed in the official FDA recall notice Z-3254-2026. If the kits are found, they should be removed from use and returned to Cardinal Health or the distributor for credit or replacement.
The recalled product
- Product
- Presource Convenience Kits: 1) KIT, PRE OP , Catalog Number: AMN548616A; 2) KIT, NICU ADMIT NEW HAN , Catalog Number: BA1DH0116B; 3) KIT, PRE PROCEDURE , Catalog Number: IVSJV8302E; 4) KIT, IV SUPPLIES , Catalog Number…
- Manufacturer
- Cardinal Health 200, LLC
- Affected units
- 17,503
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) AMN548616A
- UDI-DI: 10197106721834(each)
- 10197106721834(case)
- Lot Number: 4249818
- 2) BA1DH0116B
- UDI-DI: 10198956006331(each)
- 10198956006331(case)
- Lot Number: 5124984
- 3) BA1DH0116B
- Lot Number: 5129488
- 4) BA1DH0116B
- 5) BA1DH0116B
- Lot Number: 5188103
- 6) BA1DH0116B
- 7) BA1DH0116B
- Lot Number: 5211212
- 8) BA1DH0116B
- Lot Number: 5155824
- 9) BA1DH0116B
- Lot Number: 5211985
Distribution
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