Recall Z-0124-2020 ยท GWM Device, Monitoring, Intracranial Pressure
Integra LifeSciences Corp.
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.
| Date | Sep 12, 2019 |
| Status | Open, Classified |
| Reason | There is a potential for a progressive decline in observed ICP readings of the monitor during use. |
| Root cause | Under Investigation by firm |
| Action | 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 ema |
| Quantity | 189 |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K183406 | CereLink ICP Monitor, CereLink ICP Extension Cable Integra Lifesciences Corp., Jan 11, 2019 |