Device product
PARPARELLA-TYPE VENT TUBE, 1.02 MM, SILICONE, REF 240044, QTY 6, Rx Only, STERILE EO, GYRUS ACMI INC., Tympanostomy tube
Z-0411-2013
Product summary
- Event
- Event 63629
- Status
- Terminated
- Classification
- Class II
- Quantity
- 10 boxes/60 units
- Official record key
device-enforcement:Z-0411-2013
Official wording
Reason: One lot of tympanostomy tubes were manufactured with silicon that was found to be contaminated with ethylene vinyl acetate copolymer.
Code information: JC470075
Distribution pattern: Worldwide distribution: USA state of Kansas and country of Korea.
Derived failure modes
-
Unknown
One lot of tympanostomy tubes were manufactured with silicon that was found to be contaminated with ethylene vinyl acetate copolymer.