Recall Z-1920-2024 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Megadyne Medical Products, Inc.
MEGADYNE MEGA SOFT Pediatric Patient Return Electrode. Reusable Patient Return Electrode for patients weighing (0.8lb-50lb), (350g-22.7Kg), 66cm Long x 30.5cm Wide x 1.25cm. Electrosurgical use.
| Date | Jun 6, 2024 (initiated May 8, 2024) |
| Status | Open, Classified |
| Reason | Reports of patient burns. |
| Root cause | Device Design |
| Action | Consignees were mailed an URGENT: MEDICAL DEVICE RECALL (REMOVAL) notification, dated 5/8/24. The notification instructs consignees to examine their inventory to identify affected devices, quarantine any on-hand devices subject to the recall with a copy of the recall notice, and communicate the recall notification to all those in consignee facilities that should be informed and those facilities to which product was further distributed. Consignees are asked to return a completed Business Reply Form by email to ethicon4284@sedgwick.com or by fax at 800-978-9467. All devices subject to this recal |
| Quantity | 1270 |
| Distribution | Worldwide distribution. US nationwide including Puerto Rico; Australia, Austria, Bahrain, Belgium, Canada, Chile, Czechia, France, Germany, Greece, Hong Kong, India, Ireland, Italy, Japan, the Netherlands, Norway, Poland, Saudi Arabia, Singapore, South Africa, South Korea, Spain, Switzerland, Thail |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K080741 | MEGA SOFT REUSABLE PATIENT RETURN ELECTRODE Megadyne Medical Products, Inc., Dec 16, 2008 |