Aspen Surgical Recalls Sterile Wound Drainage Devices Due to Sterility Concerns
Aspen Surgical Products is recalling sterile wound drainage devices due to a potential compromise of the sterile barrier.
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 potential compromise of the sterile barrier for a medical device, which poses a risk of infection. This aligns with the rubric for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Aspen Surgical Products, Inc. is recalling the Saber 100ml Infection Control PVC Bulb with 150ml 3C System, Sterile (10/case). These medical devices are intended to provide manual suction and collection of fluids for closed wound drainage systems.
The recall was initiated because of a potential compromise of the sterile barrier for the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System. The affected product is identified by Product Number 310100.
The devices were distributed worldwide, including in the United States and internationally to Canada, UAE, England, Italy, Belgium, Costa Rica, and Ecuador. Users should stop using the affected devices and contact the manufacturer for instructions on return or replacement.
The recalled product
- Product
- Saber 100ml Infection Control PVC Bulb with 150ml 3C System, Sterile (10/case) Intended to provide manual suction and collection of fluids for closed wound drainage systems
- Manufacturer
- Aspen Surgical Products, Inc.
- 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)
- Product Number 310100
Distribution
Part of a larger recall action
This product is one of 19 recalled by Aspen Surgical Products, Inc. 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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