Unsterilized Jackson-Pratt surgical drain kits recalled by Cardinal Health
Cardinal Health recalls Jackson-Pratt 3-Spring Reservoir Kits because specific lots were shipped before sterilization. Unsterilized surgical devices pose risk of infection.
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: FDA Class II medical device with unsterilization hazard. No illnesses or injuries reported, making this a theoretical risk-of-harm case. However, unsterilized surgical devices pose significant infection risk, warranting High severity per the rubric.
Plain-English summary
Cardinal Health 200, LLC is recalling specific lots of Jackson-Pratt 3-Spring Reservoir Kits (400mL, 10Fr., REF SU130-402D). The affected lots are: 231251D2, 231252D2, 231253D2, 231254D2, 231255D2, 231256D2, 231151D2, 231152D2, 231153D2, 210751D2, 210752D2, 210753D2, 210754D2, 210755D2, and 210754D2. A total of 2,905 cases, each containing 12 units, were distributed.
The recall was issued after it was discovered that certain products in these lot numbers were shipped to users before undergoing sterilization. Jackson-Pratt drainage kits are post-surgical medical devices used to collect fluid from surgical sites. Unsterilized devices pose a risk of infection due to potential microbial contamination.
The affected products were distributed to healthcare facilities throughout the United States, Panama, Guatemala, Chile, Costa Rica, and Caribbean islands. Facilities and patients should immediately identify and quarantine any products matching the recalled lot numbers.
Healthcare providers and users of these products should stop using any affected units immediately and contact Cardinal Health or the FDA for return, replacement, or proper disposal instructions. Do not use these devices on patients until sterilization status is confirmed.
The recalled product
- Product
- Jackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain, 400mL, 10Fr., REF SU130-402D
- 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 (17)
- UDI/DI 50192253016428 (Case)
- 20192253016427 (Box)
- 10192253016420 (Each)
- Lot Numbers: 231251D2
- 231252D2
- 231253D2
- 231254D2
- 231255D2
- 231256D2
- 231151D2
- 231152D2
- 231153D2
- 210751D2
- 210752D2
- 210753D2
- 210754D2
- 210755D2
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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