Exsurco Medical recalls Amalgatome SD pneumatic hoses with model X101004 due to improper installation risks causing hose bursts or pressure loss. Affected units have specific serial numbers listed.
Improper installation of hand piece may result in a weakening of the internal hose connection which can cause loss of pressure to the device or a hose burst.
Exsurco Medical is recalling Amalgatome SD pneumatic hoses with model X101004 because improper installation can weaken the hose connection, potentially causing loss of pressure or a burst hose. This poses a risk of device malfunction or injury during medical procedures.
Improper installation of the hand piece can cause the internal hose connection to weaken over time. This weakening may lead to loss of pressure to the device or a sudden hose burst, which could interrupt medical procedures or cause injury.
Medical professionals using the Amalgatome SD device are most at risk, particularly those who install the pneumatic hose incorrectly. Patients using the device may also be affected if the hose fails during treatment.
Check for the model number X101004 on the hose. Affected units have specific serial numbers listed in the recall notice, including SDH201607220001 through SDH201804100130.
Look for the serial number on the hose, which should be one of the listed numbers starting with SDH201607220001 through SDH201804100130.
Improper installation of the hand piece can weaken the internal hose connection, potentially causing loss of pressure to the device or a hose burst.
Check the serial number on the hose to see if it's listed in the recall. If it is, stop using it and contact Exsurco Medical for further instructions.
The recall record does not specify a fix or remedy; affected users should check the serial number and contact the manufacturer.
We’ve drafted a message you can send Exsurco Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2291-2018 — Exsurco Medical Exsurco Medical Hello, I own a Exsurco Medical that is covered by recall Z-2291-2018 from Exsurco Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
