The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1425-2014·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 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.
Category
Medical Device — Surgical Drainage
Hazard

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

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 →

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