Aspen Surgical Recalls Sterile Bulb Evacuator Due to Sterility Concerns
Aspen Surgical Products is recalling sterile bulb evacuators because the sterile barrier may be compromised, potentially 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 potential compromise of the sterile barrier for a medical device, which poses a risk of infection (harm) but the source text does not report any specific illnesses or injuries.
Plain-English summary
Aspen Surgical Products, Inc. is recalling the Saber 100ml Infection Control PVC Bulb Evacuator, 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 due to 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 310101.
The products 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 Evacuator, 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 Care
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 310101
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.
See all 19 products in this recall →Related recalls
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