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Z-1439-2013 Class II Terminated

Recalled by Gyrus Acmi, Incorporated — Southborough, MA

FDA device recall Z-1439-2013 was initiated by Gyrus Acmi, Incorporated on May 24, 2013 and is designated Class II. Reason for recall: lack of sterility assurance The recall status is terminated (terminated May 30, 2014). Affected quantity: 100 boxes of 6 units.

Recall Details

Product Type: Devices
Report Date: June 12, 2013
Initiation Date: May 24, 2013
Termination Date: May 30, 2014
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 100 boxes of 6 units

Product Description

GYRUS ACMI, MYRINGOTOMY KNIFE DISPOSABLE, SICKLE BLADE FLAT HANDLE, REF 130715, Rx only, STERILE EO, GYRUS ACMI, INC., 136 TURNPIKE ROAD, SOUTHBOROUGH, MA 01722-2104 Disposable myringotomy knife intended to perforate the tympanic membrane to allow the placement of a bent tube or to directly provide ventilation or drainage of the middle ear.

Reason for Recall

lack of sterility assurance

Distribution Pattern

Worldwide Distribution - USA (nationwide) and countries of: Canada and United Kingdom.

Code Information

JC477666

Other recalls by Gyrus Acmi, Incorporated

Z-1952-2018 Class II — Gyrus ACMI Reusable Active Cord for Bovie/ValleyLab Generators, Catalog No C650- (April 17, 2018)
Z-1753-2015 Class II — Gyrus ACMI Diego Elite Tubeset, intended for cutting, coagulation, drilling, deb (May 8, 2015)
Z-1752-2015 Class II — Gyrus ACMI Diego Elite Tubeset; intended for cutting, coagulation, drilling, deb (May 8, 2015)
Z-0419-2015 Class II — Gyrus ACMI Disposable Falope-Ring Band Applicator Kits. REF 006889-901 and REF 0 (October 21, 2014)
Z-0411-2013 Class II — PARPARELLA-TYPE VENT TUBE, 1.02 MM, SILICONE, REF 240044, QTY 6, Rx Only, STERI (October 17, 2012)