International safety notice
Alert 2552 (Technosurveillance) Handle - Stonebreaker-Pneumatic Lithotriptor Device may not be sterilized adequately following the procedures detailed in the instructions for use.
Brazil / Anvisa · BRA · Apr 20, 2018
Key facts
| Title | Alert 2552 (Technosurveillance) Handle - Stonebreaker-Pneumatic Lithotriptor Device may not be sterilized adequately following the procedures detailed in the instructions for use. |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade name: Stonebreaker-Pneumatic Lithotriptor Technical name: Lithotripsy/Urology/Gatroenterology System ANVISA registration number: 10330710088 Risk class: III Affected model: Equipment: SBL-KIT1. Affected Lot/Series Numbers: Reference SBL-KIT1: 0900270, 0900468, 5054460, 5054461, 5684194, NS5784309, NS5784310, NS5784311, NS5784312, NS5784313, NS5784314, NS57 84315, NS5784316, NS5784317, NS5784318, NS5792890, NS5792891, NS5792892, NS5792893, NS5792894 e 5873311X. SBA-EC reference: 6241349. SBA-PC reference: 5257852 and 5943831. Reference SBA-SC: 5924492. Referência SBC-10: 09020, 4982708, U2462535, U2466275, U2466279, 5296161, 5282743, 5296161, 591920, 5919200, 5919201, 6292892, 6292896, 6292892 e 6292896. Reference SBP-010500: 09054, U2467239 and U2476031. Reference SBP-010605: U2473998, 5616732, 5676478, 5716379, 5884345, 5898498. Reference SBP-016500: 5000020 and 6028035. Reference SBP-016605: 09022, U2427745 and U2458178. Reference SBP-020425: U2067690, 5000021, U2467237, U2467241, 5676479, 5898500, 5925167, 6810029, 7081752 and 7378379. |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO HANDLE COMÉRCIO DE EQUIPAMENTOS MÉDICOS LTDA CNPJ 54756242000139 AVENIDA SANTA LUZIA Nº 801 JARDIM SUMARÉ RIBEIRÃO PRETO SP TEL 16 34561400 EMAIL RTHANDLECOMBR FABRICANTE COOK INCORPORATED 750 DANIELS WAY PO BOX 489 BLOOMINGTON IN 474020489 |
| Models | 0900468, U2473998, 09022, 6292892, 10330710088, 09020, 5676478, NS5784311, 5919201, 5257852, 7378379, 09054 and 57 more |
| Date | Apr 20, 2018 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models in FDA data
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About International device safety notices
Field safety notices, recalls and safety alerts published by about 30 national medical device regulators outside the United States, matched by Orca1 to FDA device data.
Source: National medical device regulators (as listed), compiled by Orca1