Recall Z-0411-2013— Gyrus Acmi, Incorporated
Class II · Terminated
Class II FDA medical device recall by Gyrus Acmi, Incorporated, initiated 2012-10-17, terminated 2013-04-09. FDA's recall record names no specific 510(k) clearance for this event. Product: PARPARELLA-TYPE VENT TUBE, 1.02 MM, SILICONE, REF 240044, QTY 6, Rx Only, STERILE EO, GYRUS ACMI INC., Tympanostomy tube. Reason: One lot of tympanostomy tubes were manufactured with silicon that was found to be contaminated with ethylene vinyl acetate copolymer..
- Recalling firm
- Gyrus Acmi, Incorporated
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-10-17
- Terminated
- 2013-04-09
- Firm location
- Southborough, MA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.