Severe FDA (Devices)·Z-1323-2016·Announced 2016-04-13

MicroAire French Rasp Aspiration Cannula Recalled for Bending or Breaking

MicroAire Surgical Instruments is recalling 37 units of the PAL-R4011XL French Rasp aspiration cannula because they bent or broke during surgery.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II. Under the severity rubric, an FDA Class II recall involving a structural defect in a medical device used during surgery is rated as Severe (4), as it poses a significant risk of injury or procedural failure.

Plain-English summary

MicroAire Surgical Instruments, LLC is recalling 37 units of the MicroAire PAL-R4011XL - 40cm x 4 mm Del Vecchio French Rasp aspiration cannula. The recall was initiated due to complaints that the cannula bent or broke during surgical procedures.

The affected products were distributed worldwide, including the United States (nationwide including Puerto Rico), Australia, Bangladesh, the Czech Republic, India, Japan, Lebanon, New Zealand, Norway, Singapore, Switzerland, Taiwan, and Turkey. The specific lot codes involved are 0913228216, 0414243005, 0215266350, 0415269875, and 0515271334.

Healthcare facilities and consumers should stop using the affected cannulas immediately and contact MicroAire Surgical Instruments for instructions on return or replacement.

The recalled product

Product: MicroAire PAL-R4011XL - 40cm x 4 mm Del Vecchio French Rasp aspiration cannula
Manufacturer: MicroAire Surgical Instruments, LLC
Category: Medical Device — Surgical Instruments
Hazard: structural-failure
injury
Affected units: 37

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (5)

0913228216
0414243005
0215266350
0415269875
and 0515271334.

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Same manufacturer · MicroAire Surgical Instruments, LLC

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