Z-2822-2015Class II
ASP-1021 LipoTower with Aspiration Pump and Tumescent Pump. Medical use
MicroAire Surgical Instruments, LLC / initiated 2015-06-12 / Terminated / root cause: design
MicroAire Surgical Instruments, LLC began a recall of ASP-1021 LipoTower with Aspiration Pump and Tumescent Pump. Medical use on . FDA classified it as Class II and gives the reason as "There is potential risk of electrical shock if lead wires inside the device become detached and the ground connection fails". As of , the recall status on record is Terminated, and MDM tags the root cause as design.
Recall record
- Recall number
- Z-2822-2015
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- MicroAire Surgical Instruments, LLC
- Product
- ASP-1021 LipoTower with Aspiration Pump and Tumescent Pump. Medical use.
- Product code
- MUU System, Suction, Lipoplasty
- Reason for recall
- There is potential risk of electrical shock if lead wires inside the device become detached and the ground connection fails.
- Root cause tag
- design
- FDA root cause
- Device Design
- Action
- The firm has issued FDA recall letters to all consignees. The letter have been sent out by UPS to expedite the delivery.
- Quantity in commerce
- 168, ASP-1021 LipoTower with Aspiration Pump and Tumescent Pump
- Distribution
- Nationwide Distribution.
- Product codes and lots
- Serial numbers 14101241, 4091238, 15011258, 15051279, 13101158, 15051275, 14021190, 12121111, 15051274, 14071221, 13081149, 13031123, 14021187, 14121254, 14081231, 13121173, 13111167, 13101164, 13121172, 14091234, 14111248, 14031196, 13061142, 15031264, 13121171, 13021116, 15051276, 13041131, 13101160, 14051210, 15041271, 14071222, 14051208, 15021260, 13111166, 13101163, 14111246, 13111168, 13101158, 14061212, 13081152, 13121177, 13061145, 15051280, 15061283, 14041200, 13021114, 14011184, 14031193, 13111165, 14011182, 14111249, 14101242, 14011181, 15041272, 13101156, 13041126, 14101240, 14021188, 12111108, 13061141, 12121112, 13061140, 13041128, 13081150, 14031195, 15051281, 14031197, 14081228, 14101243, 14031199, 14081232, 14071226, 13081148, 14111244, 14091238, 15051279, 13091154, 13121179, 14121252, 15041268, 14071225, 14071223, 15031266, 13031122, 13061144, 14021186, 14091233, 13101161, 14031194, 15041273, 13121170, 13021120, 13011113, 13121174, 14041201, 15021261, 14011183, 13061143, 13121175, 15021262, 15011259, 13101157, 14071227, 13091155, 13111169, 14121251, 14061211, 14071216, 14041207, 13041124, 14021189, 14011185, 14031198, 12101105, 14071224, 14041203, 14071220, 13051132, 14091239, 15041269, 14051209, 15021263, 15011257, 13081147, 13031121, 14101241, 15011258, 13041125, 13081151, 13101159, 13121176, 12121109, 14061213, 13121178 13101162, 14111245, 13061138, 14081229, 14021192, 14091237, 14121253, 13061139, 14121255, 15051278, 15051277, 14071217, 15011256, 13021118, 13071146, 13051135, 13051136, 13051137, 14071219, 14081230, 13041127, 12101106, 14061215, 12101107, 14061214, 15041267, 14041206, 14041202, 13041130, 13041129, 14021191, 13051133, 13051134, 14011180, 14091235, 14091236, 14111247, and 14111250.
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2821-2015 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-2822-2015 | Class II | Terminated | Voluntary: Firm initiated |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.
