Recall Z-1508-2020 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Stryker Corporation
Stryker, REF: 0250070460, 5.0 mm x 32 cm, Strykeprobe, Outer Sheath Replacement, RX Only, Non-Sterile, CE, UDI: (01) 07613327051971 These products are distributed with the following sheath/probe: 0250070441-PKG, StrykeFlow Electrocautery Probe, Spatula Tip 5MM 0250070442-PKG, StrykeFlow Electrocautery Probe, J Tip, 5MM 0250070443-PKG, StrykeFlow Electrocautery Probe, L Tip, 5MM 0250070444-PKG,
| Date | Sep 12, 2019 |
| Status | Terminated |
| Reason | Potential diff. in the length of the sheath tube and the sheath/probe. A diff. in length could lead to the base of the sheath/probe not being fully seated in the sheath tube which could result in the distal tip of the sheath melting. This could lead to a compromised insulation, leading to unintentional flow of electricity to the patient. The sheath/probe is packaged separately. |
| Root cause | Other |
| Action | On September 25, 2019 and November 26, 2019, the firm sent an "Urgent Medical Device Recall Notification" letter to all consignees via USPS mail. In addition, to informing consignees about the recall, they recall letter asked consignees to take the following actions: Actions to be taken by the Customer/User: 1. Inform individuals within your organization who need to be aware of this device removal. 2. Check all stock areas and/or operating room storage to determine if any devices with the affected Strykeprobe Sheath lot numbers from Attachment A are at your facility. - a. If you would like a |
| Quantity | 525 devices |
| Distribution | OUS: Netherlands, Spain, Switzerland, Colombia, Canada, Japan, Taiwan,, Puerto Rico, South Africa, and South Korea |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K963765 | STRYKER STRYKEFLOW ELECTROCAUTERY PROBES Stryker Endoscopy, Jan 31, 1997 |