Aspen Surgical Wound Drainage Kits Recalled for Sterility Concerns
Aspen Surgical Products is recalling specific wound drainage kits due to a potential compromise of the sterile barrier.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 compromise of the sterile barrier, 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 10FR Drain Kit, Flat Full Perforated with Trocar, 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.
The affected product is identified by Product Number 310017. The distribution pattern includes worldwide distribution to the United States, Puerto Rico, Canada, the UAE, England, Italy, Belgium, Costa Rica, and Ecuador. Specific US states listed in the distribution 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 providers and consumers should stop using the affected product and contact the manufacturer or their supplier for further instructions on returns or replacements.
The recalled product
- Product
- 10FR Drain Kit, Flat Full Perforated with Trocar, Saber 100ml Bulb and 3C System, 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 310017
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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