MEGADYNE Suction Coagulators, Product Code 004125 (Suction Coagulator, Handswitching, 10 Fr, 6 inch (15.24cm)), Product

FDA device recall Z-2257-2023 · posted 2023-07-28 · Open, Classified

Recall details

Recalling firm

Megadyne Medical Products, Inc.

Reason for recall

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).

Action taken

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 quarantined product and keep a copy for your records. 2. Communicate the issue to relevant operating room or materials management personnel, or anyone else in your facility who needs to be informed. If any product subject to this recall has been forwarded to another facility, contact that facility to arrange return. Please consider including a copy of this recall letter when communicating. 3. Complete the Business Reply Form (BRF) (Attachment 2) confirming receipt of this notice and fax or email to Sedgwick at 866-918-8739 or Ethicon8055@sedgwick.com within three (3) business days. Please return the BRF even if you do not have product subject to this recall. 4. Customers are required to return unused MEGADYNE" Suction Coagulators subject to this recall that are in inventory immediately. To receive credit reimbursement, customers must return product subject to this recall no later than September 30, 2023 to Sedgwick at 866-918-8739 or Ethicon8055@sedgwick.com. Any non-affected product and any product returned after the date specified will not receive credit reimbursement. 5. To return product subject to this recall, photocopy the completed BRF, place it in the box with the product, and affix the pre-paid authorized shipping label included with the recall notification letter. Megadyne will pay for the shipping charges only if the authorized label is used. Extra shipping labels may be ob

Root cause

Under Investigation by firm

Status

Open, Classified

Product code

GEI

Quantity affected

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, ITAL

Date initiated

2023-06-15

Date posted

2023-07-28

Location

Blue Ash, OH

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