TruDi NAV Suction, TDNS000Z, 0 Degree Tip Angle, (01)10705031245877
Recall
- Recall Number
- Z-0824-2020
- Event Number
- 84398
- Firm
- Acclarent, Inc.
- FEI Number
- 3005172759
- Product Code
- PGW
- Status
- Terminated
- Root Cause
- Device Design
- Initiated
- March 6, 2019
- Address
- 33 Technology Dr, Irvine, CA, 92618-2346
Description
TruDi NAV Suction, TDNS000Z, 0 Degree Tip Angle, (01)10705031245877
The firm became aware that three (3) lots of the NAV Suction Instruments contain calibration issues causing incorrect tip orientation display in the system.
On 3/6/19, affected customers were contacted via Phone concerning the recall. On 3/12/19, the firm mailed a "Urgent Medical Device Recall" letter to affected customer via FedEx overnight. In addition to informing the customers about the recall, the letter asked customers to take the following actions: 1. Evaluate your current inventory of Acclarent TruDi Nav Suction Instruments with the identified lot numbers listed above. If you have inventory of the specific lots, DO NOT USE. Remove and return products immediately. 2. To return the products, complete BOTH customer acknowledgment and product return sections of the attached Business Reply Form (BRF)). A local Acclarent sales representative will contact you to retrieve the recalled products. Use the enclosed prepaid shipping label and attach a copy of the completed BRF with your product return. 3. Complete the BRF within three (3) business days of receipt even if you no longer have inventory of the identified products. Upon receipt of the completed BRF and your product return, your account will be credited. Incomplete BRFs cannot be processed. 4. Ensure that anyone in your facility who needs to be aware of this notification reads this letter carefully. 5. Maintain a copy of this communication where the inventory of the lots identified in this letter is located until all products are returned. 6. If you have product complaints or adverse events to report regarding the use of Acclarent products, please inform Acclarent by calling (650) 687-5888 7. For questions related to this issue and product recall, please contact your Acclarent sales representative or call (650) 687-5888
US: WI, IL, NE, CA, OH, NY OUS: None
14 Suction Insstruments