MicroAire PAL Cannula Product Usage - Power Aspiration Device
This recall has been terminated (originally issued February 8, 2016).
- Recall Initiated
- February 8, 2016
- Terminated
- February 14, 2017
- Recall Number
- Z-1328-2016
- Quantity
- 145 manufactured and distributed
- Firm Location
- Charlottesville, VA
- Official Source
- View on FDA website ↗
Reason for Recall
MicroAire has initiated a recall on product PAL-R4011XL (40cm x 4mm Del Vecchio French Rasp cannula), due to our receipt of three (3) complaints that it bent or broke during surgery. Accordingly, the PAL-R4011XL has also been put on production hold until further notice.
Distribution
Worldwide Distribution - US Nationwide
Lot / Code Info
Include lot numbers/serial numbers 0913228216, 0414243005, 0215266350, 0415269875, 0515271334
Root Cause
Nonconforming Material/Component
Action Taken
The firm is sending letters to all customers who have received PAL-R4011XL from August 2013- October 2015. The firm sent these letters by UPS to expedite the delivery and for traceability.
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