Degania Silicone Jackson-Pratt Drain Recalled for Sterility Compromise
Degania Silicone is recalling 3,040 units of Jackson-Pratt Channel Drain Silicone Round because the sterile barrier was breached, compromising sterility.
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 is classified as FDA Class II. The hazard involves a breach of the sterile barrier, which poses a risk of infection (risk-of-harm product) but no specific injuries or illnesses are reported in the source text, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Degania Silicone, Ltd. is recalling 3,040 units of Jackson-Pratt Channel Drain Silicone Round, Fully Fluted w/10FR Trocar. The product is sterile and intended for wound drainage. It is distributed by Cardinal Health, USA, under catalog number JP-2187.
The recall was initiated because the product's sterility was compromised due to a breach of the sterile barrier. The affected lot number is P1546816, with an expiration date of January 2021. The distribution pattern is listed as 'To PR only.'
This is a Class II recall. Consumers and healthcare providers should stop using the affected product and contact the recalling firm or their supplier for further instructions.
The recalled product
- Product
- Jackson-Pratt Channel Drain Silicone Round, Fully Fluted w/10FR Trocar. Sterile. Rx Distributed by Cardinal Health, USA Catalog Number: JP-2187 For wound drainage.
- Manufacturer
- Degania Silicone, Ltd.
- Category
- Medical Device — Wound Drainage
- Affected units
- 3,040
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)
- Lot Number: P1546816 Expiration date: January 2021
Distribution
Distributed in 1 state:
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