Recall Z-1097-2020 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Stryker Instruments Div. of Stryker Corporation
SafeAir Telescopic Smoke Evacuation Pencil, Product No. 0703 046 004. The product is a Bovie pencil that is 75 inches long compressed, with a telescoping shaft. UDI GTIN 37613327466332
| Date | Jan 28, 2020 (initiated Jan 13, 2020) |
| Status | Terminated |
| Reason | Hairline fractures in a component could allow electrical current to arc out of the device, resulting in a burn to the patient and/or user. |
| Root cause | Under Investigation by firm |
| Action | On January 13, 2020, the firm informed customers of the recall via Urgent Medical Device Recall Notification letters. Customers were advised to take the following actions: 1. Immediately check all stock areas and/or operating room storage for affected products. Quarantine and discontinue use of any recalled Stryker SafeAir Smoke Evacuation Pencils or LINA Telescopic Smoke Pencils. 2. Complete the Business Reply Form (BRF) to confirm receipt of Notification and identify how many affected items are currently in your inventory. Please complete and return the BRF even if you dont have any aff |
| Quantity | 15150 |
| Distribution | Domestic distribution nationwide. Foreign distribution to Netherlands and Australia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K182354 | SafeAir Telescopic Smoke Pencil Lina Medical Aps, Dec 14, 2018 |