Z-0797-2010

MICRON BOBBIN VENT TUBE, 1.27 MM I.D., TITANIUM, REF 145281-ENT, QTY 1, STERILE EO, GYRUS ACMI INC., 136...

Name: Z-0797-2010 MICRON BOBBIN VENT TUBE, 1.27 MM I.D., TITANIUM, REF 145281-ENT, QTY 1, STERILE EO, GYRUS ACMI INC., 136...
Creator: Gyrus ACMI Corporation
Published: 2010-01-08
License: https://open.fda.gov/license/

Gyrus ACMI, Inc. / initiated 2010-01-08 / Terminated / root cause: sterility

FDA source

Gyrus ACMI Corporation began a recall of MICRON BOBBIN VENT TUBE, 1.27 MM I.D., TITANIUM, REF 145281-ENT, QTY 1, STERILE EO, GYRUS ACMI INC., 136 TURNPIKE ROAD, SOUTHBOROUGH, MA 01772 USA. Intended to... on 2010-01-08. The reason FDA records is "Units of the product in lot MH136952 may have been shipped without being sterilized". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-0797-2010
Status: Terminated
Initiated: 2010-01-08
Posted: 2010-03-04
Terminated: 2010-07-27
Recalling firm: Gyrus ACMI, Inc.
Product: MICRON BOBBIN VENT TUBE, 1.27 MM I.D., TITANIUM, REF 145281-ENT, QTY 1, STERILE EO, GYRUS ACMI INC., 136 TURNPIKE ROAD, SOUTHBOROUGH, MA 01772 USA. Intended to be implanted for ventilation or drainage of the middle ear.
Product code: ETD Tube, Tympanostomy
Reason for recall: Units of the product in lot MH136952 may have been shipped without being sterilized.
Root cause tag: sterility
FDA root cause: Pending
Action: The firm initiated their recall on 01/04/2010 by telephone or visit to their consignees. A follow-up Urgent: Medical Device Recall correspondence, dated 1/14/2010, was sent on 01/27/2010, return receipt requested, to both the consignees and the implanting surgeons. The follow-up letter identified the affected product and described the issue. Customers are to immediately cease any further use of any affected product and quarantine it. Also, they are to obtain a Return Goods Authorization and return the affected product to the firm. The reply form should be completed and also returned. Questions should be directed to customer service at 1-800-773-4301.
Quantity in commerce: 19 boxes of 6 units
Distribution: Nationwide Distribution -- Including states of FL, GA, OH, TX, RI, IL, MI, and KS.
Product codes and lots: Lot Number: MH136952.

Product code ETD

K820362Class IIReuter Bobbin Ventila. Tube-TitaniumRichard'S Medical Equip., Inc. / cleared 1982-03-02

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)