Aspen Surgical Recalls Sterile Wound Drainage Kits Due to Sterility Concerns
Aspen Surgical Products is recalling 7mm Drain 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 poses a risk of harm (infection) even though no specific injuries or illnesses are reported in the source text. This aligns with 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 7mm Drain Kit, Flat Full Perforated, Saber 100ml Bulb and 3C System Sterile (Product Number 310006). These medical devices are intended for closed wound suction drainage. 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 products were distributed worldwide, including in the United States and internationally to Canada, UAE, England, Italy, Belgium, Costa Rica, and Ecuador. Specific US states listed in the distribution pattern include 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.
Healthcare providers and consumers should stop using these products immediately. The potential compromise of the sterile barrier presents a risk of infection if the devices are used. Users should contact Aspen Surgical Products, Inc. for further instructions on returning or disposing of the recalled items.
The recalled product
- Product
- 7mm 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 310006
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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