Jackson-Pratt 3-Spring Reservoir Drain Kits Shipped Without Sterilization
Cardinal Health is recalling specific lots of Jackson-Pratt 3-Spring Reservoir Kits because they were shipped to users before sterilization. Unsterilized surgical drains pose an infection risk.
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 FDA Class II recall involves unsterilized surgical drains with no reported illnesses or injuries. Although unsterilized post-operative devices pose a serious infection risk, the absence of reported harm limits the score to 3 per the rubric.
Plain-English summary
Cardinal Health, Inc. is voluntarily recalling specific lots of Jackson-Pratt 3-Spring Reservoir Kits with PVC Round Drain (400mL, 7Fr., model REF SU130-401D). The affected lots are 231251D1, 231151D1, and 210751D1, distributed in 202 cases containing 12 units each.
The recalled products were shipped to users before undergoing the required sterilization process. Jackson-Pratt drains are used post-operatively to collect fluid from surgical sites, and unsterilized devices pose a risk of serious infection.
The affected kits have been distributed worldwide, including throughout the United States and to Panama, Guatemala, Chile, the Caribbean Islands, and Costa Rica.
Users who have received the affected lots should not use them. Contact your supplier or Cardinal Health for instructions on handling the affected inventory.
The recalled product
- Product
- Jackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain, 400mL, 7Fr., REF SU130-401D
- 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 (6)
- UDI/DI 50192253016411 (Case)
- 20192253016410 (Box)
- 10192253016413 (Each)
- Lot Numbers: 231251D1
- 231151D1
- 210751D1
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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