Recall Z-0972-2009 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Stryker Endoscopy
Stryker Endoscopy brand 3.5mm Super 90-S SERFAS Energy Suction Probe; Model Number: 279-351-300; Manufactured By: Stryker Endoscopy, Puerto Rico
| Date | Feb 9, 2009 (initiated Jun 20, 2008) |
| Status | Terminated |
| Reason | The probes may have inadequate suction due to obstruction, which can result in unintended ablation due to reduced visibility within the surgical area. |
| Root cause | Process control |
| Action | On 6/20/08, the firm initiated the recall and its notification was via Urgent: Device Removal letters explaining the reason for the recall. The letter recommended that recipients of the letter inspect their inventory for the part number/lot numbers listed and quarantine any of the affected product. Affected products should be returned to Stryker Endoscopy using the Pre-paid shipping label provided. Customers should call Stryker Endoscopy's Customer Service Department at 1-800-624-4422 for replacement product. Importantly, customers should sign and complete the enclosed "acknowledgment of r |
| Quantity | 2463 units |
| Distribution | Worldwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K041810 | SERFAS ENERGY SYSTEM Stryker Endoscopy, Dec 21, 2004 |