Jackson-Pratt Surgical Drain Kits Recalled for Unsterilized Shipments
Cardinal Health is voluntarily recalling Jackson-Pratt 3-Spring surgical drain kits from specific lot numbers that were shipped unsterilized. Distributed worldwide including the US, the kits pose an infection risk if used without sterilization.
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: This is an FDA Class II medical device recall for non-sterile surgical drain kits. No illnesses or injuries have been reported, placing it in the High category as a risk-of-harm product without documented injury.
Plain-English summary
Cardinal Health 200, LLC is voluntarily recalling Jackson-Pratt 3-Spring Reservoir with Silicone Adapters (400mL, REF SU130-475) because specific products in one lot were shipped to customers before completing the sterilization process. The product is a surgical drain used in post-operative care.
The recall is limited to Lot Number 231251D5, affecting approximately 98 cases of 12 units each. Distribution was worldwide, including the entire United States and the countries of Panama, Guatemala, Chile, Costa Rica, and Caribbean Islands.
Unsterilized medical devices can harbor bacteria and other pathogens, creating a risk of infection. Customers with products from the affected lot should not use them and should contact Cardinal Health for guidance on returns or replacements.
The recalled product
- Product
- Jackson-Pratt 3-Spring Reservoir with Silicone Adapters, 400mL, REF SU130-475
- Manufacturer
- Cardinal Health 200, LLC
- Category
- Medical Device — Surgical Drain
- Hazard
- non-sterile
- infection-risk
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 50885380113114 (Case)
- 10885380113116 (Each)
- Lot Numbers: 231251D5
Distribution
Distributed nationwide across the United States.
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