Agency classClass IIOur severity:High FDA (Devices)·Z-1424-2014·Announced 2014-04-16

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.

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 involves a potential compromise of the sterile barrier for a medical device, which poses a risk of infection. As no specific injuries or illnesses are reported in the source text, this falls under the 'High' category for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Aspen Surgical Products, Inc. is recalling the 10FR 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 332263. The recall covers units distributed worldwide, including 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.

Healthcare providers and consumers should stop using these devices 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 instructions on returning the product.

The recalled product

Product: 10FR 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.
Category: Medical Device — Surgical Drainage
Hazard: infection
sterility-compromise

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 332263

Distribution

Distributed in 35 states:

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 →

Same manufacturer · Aspen Surgical Products, Inc.

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Aspen Surgical Recalls Sterile Wound Drainage Kits Due to Sterility Concerns
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Same hazard · infection