Jackson-Pratt Drainage Kits Shipped Unsterilized in Voluntary Removal
Cardinal Health is voluntarily removing Jackson-Pratt drainage kits (Lot 210751D6) that were shipped without sterilization. The unsterilized devices pose an infection risk if used in patient care.
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: This is a Class II FDA recall of unsterilized medical devices intended for patient use, which constitutes a risk-of-harm product. However, no illnesses or injuries have been reported, and the manufacturer issued a voluntary precautionary removal, preventing it from being classified as Severe.
Plain-English summary
Cardinal Health 200, LLC is voluntarily removing Jackson-Pratt Universal Connector PVC Tubing Anti Reflux Transparent Y kits (product reference SU130-4601) from distribution. The affected lot is 210751D6.
These products were shipped before undergoing the required sterilization process. Medical devices used in patient care must be sterilized to prevent infection. Use of unsterilized drainage kits could introduce microbial contamination.
The affected lot was distributed worldwide, including throughout the United States and to Panama, Guatemala, Chile, Costa Rica, and Caribbean Island nations. The recall involves 64 cases of 6 units each (product identifiers: UDI/DI 50192253016459 for cases; UDI/DI 10192253016451 for individual units).
Healthcare facilities and providers that received affected units should stop using them immediately and return them to Cardinal Health. No illnesses or injuries have been reported to date.
The recalled product
- Product
- Jackson-Pratt Universal Connector PVC Tubing Anti Reflux Transparent Y, REF SU130-4601
- Manufacturer
- Cardinal Health 200, LLC
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 (3)
- UDI/DI 50192253016459 (Case)
- 10192253016451 (Each)
- Lot Numbers: 210751D6
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by Cardinal Health 200, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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