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.
What this means for you
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 and involves a potential sterile barrier compromise, which poses a risk of harm (infection) without reported illnesses or injuries in the source text.
Plain-English summary
Aspen Surgical Products, Inc. is recalling the 7mm Drain Kit Flat Full Perforated with 100ml S-Vac Bulb Evacuator, Sterile (10/case). The product is intended for closed wound suction drainage and is identified by Product Number 340006.
The recall was initiated because of a potential compromise of the sterile barrier for the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices. The agency has classified this recall as Class II.
The affected products were distributed worldwide, including in the United States and internationally to Canada, UAE, England, Italy, Belgium, Costa Rica, and Ecuador. Consumers and healthcare providers should stop using these products and contact the manufacturer for further instructions.
The recalled product
- Product
- 7mm Drain Kit Flat Full Perforated with 100ml S-Vac Bulb Evacuator, Sterile (10/case) Intended for closed wound suction drainage
- 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 340006
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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