Home / Recalls / Gyrus Acmi, Incorporated / Z-0411-2013

Z-0411-2013 Class II Terminated

Recalled by Gyrus Acmi, Incorporated — Southborough, MA

Recall Details

Product Type
Devices
Report Date
November 28, 2012
Initiation Date
October 17, 2012
Termination Date
April 9, 2013
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
10 boxes/60 units

Product Description

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

Reason for Recall

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

Distribution Pattern

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

Code Information

JC470075

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-1439-2013 Class II — GYRUS ACMI, MYRINGOTOMY KNIFE DISPOSABLE, SICKLE BLADE FLAT HANDLE, REF 130715, (May 24, 2013)