The Recall Desk
HighFDA (Devices)·Z-0690-2016·Announced 2016-02-03

Globalmed Logistix Recalls Lipogems SPA Aspiration Cannulae Due to Bending Risk

Globalmed Logistix is recalling 118 units of Lipogems SPA Aspiration Cannulae because they may bend during procedures. The affected sterile cannulae were distributed to seven states.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk of harm (bending during a procedure) where no specific injuries or illnesses have been reported in the source text.

Plain-English summary

Globalmed Logistix is recalling 118 units of Lipogems SPA Aspiration Cannulae, model LGC 13G (13G x 185mm), sterile. The recall is being conducted because the cannulae may bend during a procedure. The affected products are identified by Reference # AR1318, Lot AB 0643 and AB 0732, with an expiration date of 04/2020.

The recalled cannulae are intended for the aspiration of adipose tissue. The distribution pattern for these units includes California, Colorado, Connecticut, Florida, Georgia, New Jersey, and New York.

Consumers and healthcare providers should stop using the affected cannulae and contact Globalmed Logistix for further instructions on how to return or dispose of the product.

The recalled product

Product
Lipogems SPA Aspiration Cannulae, intended for aspiration of adipose tissue. LGC 13G (13G x 185mm), Sterile.
Manufacturer
Globalmed Logistix
Affected units
118

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 (2)

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

Distribution

Distributed in 7 states: