Cerelink ICP Monitor, Model Number 826820; intended for use as an interface between compatible strain-gauge type pressure transducers and standard physiological pressure monitoring systems.
Recall
- Recall Number
- Z-0124-2020
- Event Number
- 83831
- Firm
- Integra LifeSciences Corp.
- FEI Number
- 3003418325
- Product Code
- GWM
- Status
- Open, Classified
- Root Cause
- Under Investigation by firm
- Initiated
- September 12, 2019
- Address
- 311 Enterprise Dr, Plainsboro, NJ, 08536-3344
Description
Cerelink ICP Monitor, Model Number 826820; intended for use as an interface between compatible strain-gauge type pressure transducers and standard physiological pressure monitoring systems.
There is a potential for a progressive decline in observed ICP readings of the monitor during use.
On 9/12/19, the customers were notified by a visit from the Sales Representative who delivered a notification letter at that time. The letter, URGENT: VOLUNTARY MEDICAL DEVICE RECALL, dated 9/12/19, included the following instructions: 1. If you have a CereLink ICP monitor, Model #826820, discontinue using the product as soon as clinically possible and remove the product from service. 2. Your sales representative will facilitate the return of your monitor. 3. Complete the information on the Acknowledgement Form attached to this letter and either provide it to your sales representative or email or fax as indicated on the form. Keep a copy of the form for your records. Should you have any questions regarding these instructions, please contact Customer Service Monday to Friday 8:00 AM 8:00 PM EST USA: 1-800-654-2873: email: [email protected] Outside USA: 781-565-1401
The products were distributed to the following US states: CA, CO, CT, FL, IN, NY, OK, PA, TX, WI, and WV. The products were distributed to the following foreign countries: Australia, Belgium.
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