CLASS II Device recall · Reported 16 Apr 2014 · FDA Enforcement Report

Drain Kit Flat 3/4 Perforated with Trocar recalled

Aspen Surgical Products is recalling Drain Kit Flat 3/4 Perforated with Trocar and S-Vac Bulb Evacuator, Sterile Intended for, distributed nationwide in the US. The recall was initiated on 20 Mar 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesProduct Number 340001

Quantity recalledN/A

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1427-2014
FDA event ID: 67757
Recalling firm: Aspen Surgical Products, Caledonia, MI
Classification: Class II
Status: Terminated
Recall initiated: 20 Mar 2014
FDA classified: 7 Apr 2014
Reported: 16 Apr 2014
Type: Voluntary: Firm initiated
Customers notified by: N/A
Reason category: Sterility
Device type: Surgical Instruments

Timeline

20 Mar 2014	Recall initiated by company
7 Apr 2014	Classified by FDA	+18 days
16 Apr 2014	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

10mm Drain Kit Flat 3/4 Perforated with Trocar and 100ml S-Vac Bulb Evacuator, Sterile (10/case) Intended for closed wound suction drainage

Where it was distributed

Worldwide Distribution - USA including LA, MA, NH, TX, FL, OH, NC, PA, CA, UT, TN, MI, CO, WY, OK, WA, MN, PA, IN, VA, IA, IL, MD, CT, DE, SC, NY, AR, MA, AZ, NJ, MO, GA, KS, WV, NE, NC, Puerto Rico, and Internationally to Canada, UAE, England, Italy, Belgium, Costa Rica, and Ecuador.

Nationwide Arkansas Arizona California Colorado Connecticut Delaware Florida Georgia Iowa Illinois Indiana Kansas Louisiana Massachusetts Maryland Michigan Minnesota Missouri North Carolina Nebraska

Questions about this recall

Is Drain Kit Flat 3/4 Perforated with Trocar and S-Vac Bulb Evacuator, Sterile Intended for recalled?

Yes. Aspen Surgical Products recalled Drain Kit Flat 3/4 Perforated with Trocar and S-Vac Bulb Evacuator, Sterile Intended for on 20 Mar 2014. The recall is Class II and its status is Terminated. Recall number Z-1427-2014.

Why was it recalled?

The recall has been initiated due to a potential compromise of the sterile barrier of the Surgidyne Wound Drainage and Surgidyne Bulb Evacuator & Collection System medical devices.

Which lots are affected?

Product Number 340001

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Aspen Surgical Products

All 23

Reported	Class	Recall	Company	Reason	Where
8 Sep 2021Device	CLASS II	Marco Shoulder Stabilization Kit, Product recalled	Aspen Surgical Products	Sterility	Nationwide
8 Sep 2021Device	CLASS II	Jessie Sterile Arm Suspension Kit, Product recalled	Aspen Surgical Products	Sterility	Nationwide
8 Sep 2021Device	CLASS II	Norton Arm Kit, Product recalled by Aspen Surgical Products	Aspen Surgical Products	Sterility	Nationwide
16 Apr 2014Device	CLASS II	Drain Kit Full Fluted with Trocar and S-Vac Bulb recalled	Aspen Surgical Products	Sterility	Nationwide
16 Apr 2014Device	CLASS II	Drain Kit Flat Full Perforated with Trocar, Saber Bulb recalled	Aspen Surgical Products	Sterility	Nationwide

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