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Lipogems SPA Aspiration Cannulae, intended for aspiration of adipose tissue. LGC 13G (13G x 185m...

FDA Recall #Z-0690-2016 — Class II — December 15, 2015

Recall #Z-0690-2016 Date: December 15, 2015 Classification: Class II Status: Terminated

Product Description

Lipogems SPA Aspiration Cannulae, intended for aspiration of adipose tissue. LGC 13G (13G x 185mm), Sterile.

Reason for Recall

The cannulae may bend during procedure.

Recalling Firm

Globalmed Logistix — Norcross, GA

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Devices

Product Quantity

118 units

Distribution

CA, CO, CT, FL, GA, NJ and NY.

Code Information

Ref # AR1318, Lot AB 0643 and AB 0732. Expiration date 04/2020.

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.

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