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| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0690-2016 | Class II | Terminated | Voluntary: Firm initiated |
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