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 poses a risk of harm (infection) 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 15FR Drain Kit Full Fluted with Trocar and 100ml S-Vac Bulb, Sterile (10/case). 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 product is identified by Product Number 332264. The recall covers units distributed worldwide, including the United States, Puerto Rico, Canada, the 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, and NE.
Healthcare facilities and consumers should stop using these devices and contact Aspen Surgical Products for further instructions. The potential compromise of the sterile barrier poses a risk of infection if the devices are used.
The recalled product
- Product
- 15FR Drain Kit Full Fluted with Trocar and 100ml S-Vac Bulb, Sterile (10/case) Intended for closed wound suction drainage
- Manufacturer
- Aspen Surgical Products, Inc.
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 332264
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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