Z-2888-2016 Class II Terminated
FDA device recall Z-2888-2016 was initiated by Spiegelberg Gmbh & Co. KG on December 29, 2009 and is designated Class II. Reason for recall: 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… The recall status is terminated (terminated October 5, 2016). Affected quantity: 22 units.
Recall Details
- Product Type
- Devices
- Report Date
- October 5, 2016
- Initiation Date
- December 29, 2009
- Termination Date
- October 5, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 22 units
Product Description
Spiegelberg Brain Pressure Monitoring System Probe 3PN, REF: SNDI3.1.531FV534P and Probe 3PS, REF: SNDI3.1.63/FV535P Product Usage: lntracranial pressure measuring probes are used to measure intracranial pressure (intracranial pressure, ICP), so the pressure in the head.
Reason for Recall
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.
Distribution Pattern
Nationwide Distribution to PA only
Code Information
Probe 3PN SND1 3.1 .53/FV534P: SNs: 12835-1 3393; Probe 3PS SND13.1 .63/FV535P: SNs: 6937-7122