Aspen Surgical Products Recalls Sterile Wound Drainage Kits
Aspen Surgical Products is recalling sterile wound drainage kits 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 harm (infection) even though no specific illnesses or injuries are reported in the source text.
Plain-English summary
Aspen Surgical Products, Inc. is recalling the 15FR Drain Kit, Flat Full Perforated with Trocar, Saber 100ml Bulb and 3C System, Sterile (10/case). These medical devices are intended for closed wound suction drainage.
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 source text does not specify the exact cause of the barrier compromise or report any specific illnesses or injuries.
The affected products were distributed worldwide, including in the United States and internationally to Canada, UAE, England, Italy, Belgium, Costa Rica, and Ecuador. The source text does not provide specific instructions for consumers or healthcare providers on how to handle the recalled items.
The recalled product
- Product
- 15FR Drain Kit, Flat Full Perforated with Trocar, Saber 100ml Bulb and 3C System, Sterile (10/case) Intended for closed wound suction drainage
- Manufacturer
- Aspen Surgical Products, Inc.
- Category
- Medical Device — Wound Drainage
- Hazard
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 310018
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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