Spiegelberg Brain Pressure Monitoring System Probe 3PN recall
Spiegelberg Brain Pressure Monitoring System Probe 3PN, REF: SNDI3.1.531FV534P and Probe 3PS, REF: SNDI3.1.63/FV535P Product Usage: lntracranial…
Why was Spiegelberg Brain Pressure Monitoring System Probe 3PN 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Probe 3PN SND1 3.1 .53/FV534P: SNs: 12835-1 3393; Probe 3PS SND13.1 .63/FV535P: SNs: 6937-7122
- Product
- Spiegelberg Brain Pressure Monitoring System Probe 3PN, REF: SNDI3.1.531FV534P and Probe 3PS, REF: SNDI3.1.63/FV535P Product Usage: lntracranial…
- Recalling firm
- Spiegelberg Gmbh & Co. KG
- Quantity
- 22 units
- Distribution
- Nationwide Distribution to PA only
- Recall date
- October 5, 2016
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)