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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Hazard
- 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
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