Aspen Surgical Products 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 increasing the risk of infection.
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. The hazard involves a potential compromise of the sterile barrier, which poses a risk of harm (infection) to patients, but the source text does not report any specific illnesses or injuries, fitting the criteria for a High severity score.
Plain-English summary
Aspen Surgical Products, Inc. is recalling the 19FR Drain Kit Flat Full Perforated with Trocar, Saber 100ml Bulb and 3CSystem, 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 340019. 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), Puerto Rico, and internationally to Canada, UAE, England, Italy, Belgium, Costa Rica, and Ecuador.
Healthcare providers and facilities should stop using the affected sterile wound drainage kits and contact Aspen Surgical Products, Inc. for instructions on return or replacement. Patients who have received these devices should consult their healthcare provider if they have concerns regarding the sterility of the equipment used during their procedure.
The recalled product
- Product
- 19FR Drain Kit Flat Full Perforated with Trocar, Saber 100ml Bulb and 3CSystem, Sterile (10/case) Intended for closed wound suction drainage
- Manufacturer
- Aspen Surgical Products, Inc.
- Category
- Medical Device — Surgical Drains
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 340019
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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