Z-0411-2013Class II

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

Name: Z-0411-2013 PARPARELLA-TYPE VENT TUBE, 1.02 MM, SILICONE, REF 240044, QTY 6, Rx Only, STERILE EO, GYRUS ACMI INC...
Creator: Gyrus Acmi, Incorporated
Published: 2012-10-17
License: https://open.fda.gov/license/

Gyrus ACMI, Inc. / initiated 2012-10-17 / Terminated / root cause: manufacturing process

FDA source

Gyrus Acmi, Incorporated began a recall of PARPARELLA-TYPE VENT TUBE, 1.02 MM, SILICONE, REF 240044, QTY 6, Rx Only, STERILE EO, GYRUS ACMI INC., Tympanostomy tube on 2012-10-17. FDA classified it as Class II and gives the reason as "One lot of tympanostomy tubes were manufactured with silicon that was found to be contaminated with ethylene vinyl acetate copolymer". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0411-2013
Classification: Class II
Status: Terminated
Initiated: 2012-10-17
Posted: 2012-11-20
Terminated: 2013-04-09
Recalling firm: Gyrus ACMI, Inc.
Product: PARPARELLA-TYPE VENT TUBE, 1.02 MM, SILICONE, REF 240044, QTY 6, Rx Only, STERILE EO, GYRUS ACMI INC., Tympanostomy tube
Product code: ETD Tube, Tympanostomy
Reason for recall: One lot of tympanostomy tubes were manufactured with silicon that was found to be contaminated with ethylene vinyl acetate copolymer.
Root cause tag: manufacturing process
FDA root cause: Material/Component Contamination
Action: The firm, Olympus, sent an "URGENT: Medical Device Recall" letter dated October 15, 2012 to their consignees/customers. The letter describes the product, problem and actions to be taken. The customers were instructed to inspect their stock to confirm if any of the affected lot of product remains in their possession; immediately cease any further use of any affected product; remove it from their stockroom and quarantine it until it is shipped back to Gyrus ACMI, Inc.; call their Gyrus ACMI customer service representative (800-773-4301) to obtain a Returned Goods Authorization and promptly return any affected product to Gyrus ACMI, Inc., 2925 Appling Rd, Bartlett, TN 38133., and complete and return the RECALL REPLY FORM to Attn: Regulatory Affairs via fax to: (508) 804-2624, even if there is no affected stock left at your facility. If you have any questions, contact the customer service at 800-773-4301.
Quantity in commerce: 10 boxes/60 units
Distribution: Worldwide distribution: USA state of Kansas and country of Korea.
Product codes and lots: JC470075

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0411-2013
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0411-2013	Class II	Terminated	Voluntary: Firm initiated	2012-11-28	2012-11-20

Product code ETD

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)