Smith & Nephew Wound Drain Recall Due to Breakage Risk
Smith & Nephew is recalling 15FR and 19FR channel wound drains because they may break during use or removal, requiring additional surgery.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of significant injury requiring additional surgical intervention to remove a broken device from the patient's body.
Plain-English summary
Smith & Nephew is recalling 15FR and 19FR round fluted drain channel wound drains (PN: 02872) manufactured by Degania Silicone, Ltd. The recall involves 2,700 units distributed nationwide. The affected lot codes are P1838322 and P1858869.
The recall was initiated because the drains may break during use, particularly during removal, at the connection point between the clear tube and the white profile part. If the drain breaks, additional surgical intervention is required to remove the broken end from the patient's body.
Healthcare providers and patients should check their inventory and patient records for these specific lot codes. If a drain from these lots is in use or has been used, contact the manufacturer or the FDA for further instructions on management and removal.
The recalled product
- Product
- Smith & Nephew Negative Pressure Wound Therapy 15FR Channel Wound Drain PN: 02872 An introduction/drainage catheter is a device that is a flexible single or multilumen tube intended to be used to introduce nondrug fluids into body cavities other than blood vessels, drain…
- Manufacturer
- Degania Silicone, Ltd.
- Category
- Medical Device — Wound Care
- Affected units
- 2,700
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 (2)
- Lot Code: P1838322
- P1858869
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 8 recalled by Degania Silicone, Ltd. 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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