Recall Z-1323-2016 ยท BTA Pump, Portable, Aspiration (Manual Or Powered)
MicroAire Surgical Instruments, LLC
MicroAire PAL-R4011XL - 40cm x 4 mm Del Vecchio French Rasp aspiration cannula
| Date | Feb 8, 2016 |
| Status | Terminated |
| Reason | Complaints that the cannula bent/broke during surgery. |
| Root cause | Component design/selection |
| Action | 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. |
| Quantity | 37 |
| Distribution | Worldwide Distribution. US nationwide including Puerto Rico, Australia, Bangladesh, Czech Republic, India, Japan, Lebanon, New Zealand, Norway, Singapore, Switzerland, Taiwan, and Turkey. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K973268 | MICROAIRE POWER ASPIRATION DEVICE PAD SYSTEM Microaire Surgical Instruments, Inc., Nov 26, 1997 |