CLASS II Device recall · Reported 28 Nov 2012 · FDA Enforcement Report

Parparella-type Vent Tube, Silicone recalled by Gyrus Acmi, Incorporated

Gyrus Acmi, Incorporated is recalling Parparella-type Vent Tube, Silicone, distributed in Kansas. The recall was initiated on 17 Oct 2012 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesJC470075

Quantity recalled10 boxes/60 units

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-0411-2013
FDA event ID: 63629
Recalling firm: Gyrus Acmi, Incorporated, Southborough, MA
Classification: Class II
Status: Terminated
Recall initiated: 17 Oct 2012
FDA classified: 20 Nov 2012
Reported: 28 Nov 2012
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Other Medical Devices

Timeline

17 Oct 2012	Recall initiated by company
20 Nov 2012	Classified by FDA	+34 days
28 Nov 2012	Published in enforcement report	+8 days

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

Reason for recall

One lot of tympanostomy tubes were manufactured with silicon that was found to be contaminated with ethylene vinyl acetate copolymer.

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

PARPARELLA-TYPE VENT TUBE, 1.02 MM, SILICONE, REF 240044, QTY 6, Rx Only, STERILE EO, GYRUS ACMI INC., Tympanostomy tube

Where it was distributed

Worldwide distribution: USA state of Kansas and country of Korea.

Kansas

Questions about this recall

Is Parparella-type Vent Tube, Silicone recalled?

Yes. Gyrus Acmi, Incorporated recalled Parparella-type Vent Tube, Silicone on 17 Oct 2012. The recall is Class II and its status is Terminated. Recall number Z-0411-2013.

Why was it recalled?

One lot of tympanostomy tubes were manufactured with silicon that was found to be contaminated with ethylene vinyl acetate copolymer.

Which lots are affected?

JC470075

Where was it sold?

Worldwide distribution: USA state of Kansas and country of Korea.

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.

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