Cardinal Health Recalls Jackson-Pratt Silicone Round Drains Due to Seal Compromise
Cardinal Health 200, LLC is recalling Jackson-Pratt Silicone Round Drains because the product seal may be compromised, potentially compromising sterility and increasing 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: The recall involves a risk-of-harm product (sterile medical device) where injury (infection) has not yet been reported, fitting the 'High' severity criteria for theoretical risk without confirmed illness.
Plain-English summary
Cardinal Health 200, LLC is recalling Jackson-Pratt Silicone Round Drains, 7FR, sterile, prescription-only, single-use devices. The recall is due to a potential compromise in the product's seal, which may compromise the sterility of the package contents.
The affected products are wound drainage systems consisting of a wound drain and a fluid collection reservoir, used to remove exudates from surgical wound sites. The specific catalog number is SU130-1320, and the affected lot numbers are 1161205, 1161368, 1161369, and 1161475. The products were distributed nationwide.
Use of the impacted products could result in an increased risk of infection. Healthcare providers and facilities should check their inventory for these specific lot numbers and discontinue use of any affected units.
The recalled product
- Product
- Jackson-Pratt Silicone Round Drain, 7FR. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section…
- Manufacturer
- Cardinal Health 200, LLC
- Category
- Medical Device — Wound Drainage
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 (1)
- Catalog Number: SU130-1320 Lot Numbers: 1161205 1161368 1161369 1161475
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 20 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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