Aspen Surgical Recalls Sterile Wound Drainage Kits Due to Sterility Concerns
Aspen Surgical Products is recalling sterile wound drainage kits because the sterile barrier may be compromised, potentially exposing patients to 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, which is a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Aspen Surgical Products, Inc. is recalling the 7mm Drain Kit Fluted 4 Channel with 100ml S-Vac Bulb, Sterile (10/case), Product Number 322205. These devices are intended for closed wound suction drainage and are marketed under the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System names.
The recall was initiated due to a potential compromise of the sterile barrier for these medical devices. A compromised sterile barrier could allow contamination, posing a risk of infection to patients using the products.
The affected products were distributed worldwide, including in the United States (specifically listing 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. Users should stop using these products and contact the manufacturer or their supplier for instructions on return or replacement.
The recalled product
- Product
- 7mm Drain Kit Fluted 4 Channel with 100ml S-Vac Bulb, 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 322205
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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