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MULTISTIM SENSOR

Pajunk GmbH Medizintechnologie · Model 1151-94-18 · UDI-DI 04048223075883

BXN
10
510(k) clearances
31
Adverse events
5
Recalls
19
Facilities

Description

1151-94-18

Recalls

DateFirmReason
2024-05-17B Braun Medical IncThe devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used contains traces of DEHP.
2024-05-17B Braun Medical IncThe devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used contains traces of DEHP.
2024-05-17B Braun Medical IncThe devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used contains traces of DEHP.
2024-05-17B Braun Medical IncThe devices are labeled "not made with DEHP" or the DEHP free symbol; however, the glue used contains traces of DEHP.
2010-02-01Stryker Instruments Div. of Stryker CorporationDevice may malfunction and lead to ineffective stimulation, which could delay finding the nerve and the effects of the nerve block.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.