Jackson-Pratt 3-Spring Reservoir Kit Recalled Due to Non-Sterile Shipment
Cardinal Health is recalling Jackson-Pratt 3-Spring Reservoir Kits after shipping specific lots before sterilization. The affected devices pose an infection risk if used without proper sterilization.
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 recall of a surgical drainage device issued because products were shipped before sterilization. The product is a risk-of-harm medical device used in post-surgical care, and non-sterility could result in infection.
Plain-English summary
Cardinal Health 200, LLC is recalling specific lots of the Jackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain, 400mL, 15Fr. (REF SU130-403D). The affected lot number is 210751D3, totaling 128 cases of 12 units.
The recall was issued because these products were shipped to users before undergoing required sterilization. Jackson-Pratt drain kits are medical devices used in post-surgical care and must be sterile to prevent infection from contamination.
The affected products were distributed worldwide, including across the United States and to Panama, Guatemala, Chile, the Caribbean Islands, and Costa Rica.
The recalled product
- Product
- Jackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain, 400mL, 15Fr., REF SU130-403D
- Manufacturer
- Cardinal Health 200, LLC
- Category
- Medical Device — Surgical Drain
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 (4)
- UDI/DI 50192253016435 (Case)
- 20192253016434 (Box)
- 10192253016437 (Each)
- Lot Numbers: 210751D3
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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