Reported Oct 5, 2016 · Terminated
Spiegelberg Brain Pressure Monitoring System Probe 3PN, REF: SNDI3.1.531FV534P and Probe 3PS, REF: SNDI3.1.63/FV535P…
Spiegelberg GmbH & Co. KG
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Spiegelberg Gmbh & Co. KG · Tempowerkring 4 · Hamburg, N/A · N/A
Is this the product you have?
- Spiegelberg Brain Pressure Monitoring System Probe 3PN
- REFSNDI3.1.531FV534P and Probe 3PS
- REFSNDI3.1.63/FV535P
- Product Usagelntracranial pressure measuring probes are used to measure intracranial pressure (intracranial pressure, ICP), so the pressure in the head
- Lot codes and dates
- Probe 3PN SND1 3.1 .53/FV534P:
- SNs
12835-1 3393Probe 3PS SND13.1 .63/FV535P:
- SNs6937-7122
- Amount recalled
- 22 units
Where it was sold
- Nationwide
- PA
Why it was recalled
In the vast majority of products specified, a shrinkage of the air chamber during sterilization has occurred. Because of these false high readings were displayed in the lower measuring range from 0 to 20 mmHg. The observed measurement error was particularly at the lowest end of the range (to 0 mmHg) up to 8 mmHg.
This product could cause temporary or reversible health problems — stop using it.
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