FDAFDA · Food and drugs·Recall number Z-0411-2013
PARPARELLA-TYPE VENT TUBE, 1.02 MM, SILICONE, REF 240044, QTY 6, Rx Only, STERILE EO, GYRUS ACMI INC., Tympanostomy tube
Published November 28, 2012 · Recall initiated: October 17, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
One lot of tympanostomy tubes were manufactured with silicon that was found to be contaminated with ethylene vinyl acetate copolymer.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Gyrus Acmi, Incorporated
- Distributor
- Worldwide distribution: USA state of Kansas and country of Korea.
- Lot
- JC470075
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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