Agency classClass IIOur severity:High FDA (Devices)·Z-1426-2014·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, posing a 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 involves a potential compromise of the sterile barrier for a medical device used in wounds, which poses a risk of infection (harm) but the source text does not report any specific injuries or illnesses.

Plain-English summary

Aspen Surgical Products, Inc. is recalling the 19FR Drain Kit Full Fluted with Trocar and 100ml S-Vac Bulb, Sterile (10/case), Product Number 332265. 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 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 devices immediately and contact Aspen Surgical Products, Inc. for instructions on return or replacement. Using a device with a compromised sterile barrier can introduce pathogens into a wound, leading to infection.

The recalled product

Product: 19FR 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 — Wound Care
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 332265

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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Same hazard · infection