Z-0411-2013 Class II Terminated
FDA device recall Z-0411-2013 was initiated by Gyrus Acmi, Incorporated on October 17, 2012 and is designated Class II. Reason for recall: One lot of tympanostomy tubes were manufactured with silicon that was found to be contaminated with ethylene vinyl acetate copolymer. The recall status is terminated (terminated April 9, 2013). Affected quantity: 10 boxes/60 units.
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