Recall Z-2257-2023 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Megadyne Medical Products, Inc.
MEGADYNE Suction Coagulators, Product Code 004125 (Suction Coagulator, Handswitching, 10 Fr, 6 inch (15.24cm)), Product Code 004225 (Suction Coagulator, Handswitching, 8 Fr, 6 inch (15.24cm), Product Code 004325 (Suction Coagulator, Handswitching, 12 Fr, 6 inch (15.24cm)), and Product Code 0041BN (Suction Coagulator, Handswitching, 10 Fr, 6 inch (15.24cm), Bulk Non Sterile)
| Date | Jul 28, 2023 (initiated Jun 15, 2023) |
| Status | Open, Classified |
| Reason | An issue with the Suction Coagulator product family may lead to fluid ingress into the handpiece. Fluid ingress can lead to intermittent device activation, non-activation, or self-activation when plugged into the electrosurgery unit (ESU). |
| Root cause | Under Investigation by firm |
| Action | An "URGENT: MEDICAL DEVICE RECALL (REMOVAL)" letter dated 6/15/23 was sent to customers. If you have additional questions regarding this recall or to report any customer complaints, please contact the Ethicon Resource Department at 1-877-ETHICON (1-877-384-4266). The Ethicon Resource Department is open Monday through Friday, 8:00 AM to 5:00 PM ET. ACTION REQUIRED 1. Examine your inventory immediately to determine if you have product subject to this recall on hand and quarantine such product(s). If you have product subject to this recall, please maintain a copy of this notice with the quarant |
| Quantity | 241,457 units |
| Distribution | Worldwide Distributions: US (Nationwide) and OUS (Foreign) in countries of: AUSTRALIA, BELGIUM, CANADA, CHILE, DENMARK, EGYPT, FINLAND, FRANCE, GERMANY, GREECE, HONG KONG, INDIA, IRELAND, ISRAEL, ITALY, NEW ZEALAND, NORWAY, RUSSIA, SAUDI ARABIA, SINGAPORE, SOUTH AFRICA, SOUTH KOREA, SPAIN, SWEDEN, U |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K072559 | SUCTION COAGULATOR Megadyne Medical Products, Inc., Oct 5, 2007 |