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EHL-Probe

Walz Elektronik GmbH · Model P303000SST · UDI-DI 04260667540134

FFK Prescription
1
510(k) clearances
438
Adverse events (9 deaths)
21
Recalls
34
Facilities

Description

Diamaeter of 3 Fr. with a length of 3 meter. Proximally reinforced.

Recalls

DateFirmReason
2022-04-13Northgate Technologies, Inc.Product labeled incorrectly.
2021-10-25Northgate Technologies, Inc.The languages for Russian, Romanian, Slovak, and Czech have the power settings for high and low switched in the device.
2020-03-10Northgate Technologies, Inc.As part of an investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing.
2020-03-10Northgate Technologies, Inc.Investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing.
2020-03-10Northgate Technologies, Inc.Investigation into a biocompatibility test discrepancy where a lot failed biocompatibility testing.
2018-01-31Cook Inc.The interior of the product may not be sterilized to the appropriate Sterility Assurance Level when following the reprocessing instructions in the Instructions for Use.
2018-01-31Cook Inc.The interior of the product may not be sterilized to the appropriate Sterility Assurance Level when following the reprocessing instructions in the Instructions for Use.
2018-01-31Cook Inc.The interior of the product may not be sterilized to the appropriate Sterility Assurance Level when following the reprocessing instructions in the Instructions for Use.
2018-01-31Cook Inc.The interior of the product may not be sterilized to the appropriate Sterility Assurance Level when following the reprocessing instructions in the Instructions for Use.
2018-01-31Cook Inc.The interior of the product may not be sterilized to the appropriate Sterility Assurance Level when following the reprocessing instructions in the Instructions for Use.

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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.