Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0690-2016Class II

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

Globalmed Logistix LLC / initiated 2015-12-15 / Terminated

Globalmed Logistix began a recall of Lipogems SPA Aspiration Cannulae, intended for aspiration of adipose tissue. LGC 13G (13G x 185mm), Sterile on . FDA classified it as Class II and gives the reason as "The cannulae may bend during procedure". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0690-2016
Classification
Class II
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Globalmed Logistix LLC
Product
Lipogems SPA Aspiration Cannulae, intended for aspiration of adipose tissue. LGC 13G (13G x 185mm), Sterile.
Product code
MUU System, Suction, Lipoplasty
Reason for recall
The cannulae may bend during procedure.
FDA root cause
Under Investigation by firm
Action
Consignees were notified by telephone and letter via FedEx on/about 12/15/2015.
Quantity in commerce
118 units
Distribution
CA, CO, CT, FL, GA, NJ and NY.
Product codes and lots
Ref # AR1318, Lot AB 0643 and AB 0732. Expiration date 04/2020.

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-0690-2016
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-0690-2016Class IITerminatedVoluntary: Firm initiated