Aspen Surgical 10mm Drain Kit Recalled for Sterile Barrier Compromise
Aspen Surgical Products is recalling 10mm Drain Kits due to a potential compromise of the sterile barrier, posing a risk of infection.
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 involves a potential compromise of the sterile barrier for a medical device used in wound drainage, which poses a risk of infection (harm) but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Aspen Surgical Products, Inc. is recalling the 10mm Drain Kit, Flat Full Perforated, 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 medical devices.
The affected products are identified by Product Number 310007. The distribution pattern includes worldwide distribution to the USA (including specific states such as LA, MA, NH, TX, FL, OH, NC, PA, CA, UT, TN, MI, CO, WY, OK, WA, MN, IN, VA, IA, IL, MD, CT, DE, SC, NY, AR, AZ, NJ, MO, GA, KS, WV, NE, and Puerto Rico) and internationally to Canada, UAE, England, Italy, Belgium, Costa Rica, and Ecuador.
Healthcare providers and consumers should stop using these products immediately. The potential compromise of the sterile barrier could lead to the introduction of contaminants into the wound site, increasing the risk of infection. Users should contact the manufacturer or their supplier for further instructions on returns or replacements.
The recalled product
- Product
- 10mm Drain Kit, Flat Full Perforated, 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
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 310007
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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