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

Saber Infection Control PVC Bulb with 3C System recalled

Aspen Surgical Products is recalling Saber Infection Control PVC Bulb with 3C System, Sterile Intended to provide manual, distributed in 35 states. 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 310100

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-1421-2014
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: Other Medical Devices

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

Saber 100ml Infection Control PVC Bulb with 150ml 3C System, Sterile (10/case) Intended to provide manual suction and collection of fluids for closed wound drainage systems

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.

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

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 310100

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

Other products in this recall event

18 other products · FDA event 67757

This product is part of a recall event; the main page for the event is Drain Kit Full Fluted with Trocar and S-Vac Bulb recalled.

Reported	Class	Recall	Company	Reason	Where
16 Apr 2014	CLASS II	Drain Kit Full Fluted with Trocar and S-Vac Bulb recalled	Aspen Surgical Products	Sterility	35 states
16 Apr 2014	CLASS II	Drain Kit Fluted 4 Channel with S-Vac Bulb recalled	Aspen Surgical Products	Sterility	35 states
16 Apr 2014	CLASS II	Drain Kit Flat 3/4 Perforated with Trocar recalled	Aspen Surgical Products	Sterility	35 states
16 Apr 2014	CLASS II	Drain Kit Flat 3/4 Perforated with S-Vac Bulb Evacuator recalled	Aspen Surgical Products	Sterility	35 states
16 Apr 2014	CLASS II	Drain Kit Flat Full Perforated with Trocar recalled	Aspen Surgical Products	Sterility	35 states
16 Apr 2014	CLASS II	Saber Infection Control PVC Bulb Evacuator recalled	Aspen Surgical Products	Sterility	35 states
16 Apr 2014	CLASS II	Drain Kit Round End Perforated with Trocar recalled	Aspen Surgical Products	Sterility	35 states
16 Apr 2014	CLASS II	Drain Kit Flat 3/4 Perforated with S-Vac Bulb Evacuator recalled	Aspen Surgical Products	Sterility	35 states
16 Apr 2014	CLASS II	Drain Kit, Flat Full Perforated, Saber Bulb recalled	Aspen Surgical Products	Sterility	35 states
16 Apr 2014	CLASS II	Drain Kit Full Fluted with Trocar and S-Vac Bulb recalled	Aspen Surgical Products	Sterility	35 states
16 Apr 2014	CLASS II	Drain Kit, Flat Full Perforated with Trocar, Saber Bulb recalled	Aspen Surgical Products	Sterility	35 states
16 Apr 2014	CLASS II	Drain Kit Flat Full Perforated with S-Vac Bulb Evacuator recalled	Aspen Surgical Products	Sterility	35 states
16 Apr 2014	CLASS II	Drain Kit, Flat Full Perforated, Saber Bulb recalled	Aspen Surgical Products	Sterility	35 states
16 Apr 2014	CLASS II	Drain Kit Flat Full Perforated with S-Vac Bulb Evacuator recalled	Aspen Surgical Products	Sterility	35 states
16 Apr 2014	CLASS II	Drain Kit, Flat Full Perforated with Trocar, Saber Bulb recalled	Aspen Surgical Products	Sterility	35 states
16 Apr 2014	CLASS II	Drain Kit Flat Full Perforated with Trocar recalled	Aspen Surgical Products	Sterility	35 states
16 Apr 2014	CLASS II	Drain Kit Flat Full Perforated with Trocar, Saber Bulb recalled	Aspen Surgical Products	Sterility	35 states
16 Apr 2014	CLASS II	Drain Kit Full Fluted with Trocar and S-Vac Bulb recalled	Aspen Surgical Products	Sterility	35 states

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	35 states
16 Apr 2014Device	CLASS II	Drain Kit Flat Full Perforated with Trocar, Saber Bulb recalled	Aspen Surgical Products	Sterility	35 states

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