MEGADYNE MEGA SOFT Pediatric Patient Return Electrode. Reusable Patient Return Electrode for patients weighing (0.8lb-50

FDA device recall Z-1920-2024 · posted 2024-06-06 · Open, Classified

Recall details

Recalling firm

Megadyne Medical Products, Inc.

Reason for recall

Reports of patient burns.

Action taken

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 recall are to be returned immediately; for credit reimbursement customers must return product no later than 8/31/2024. To return product, consignees are to include a photocopy of the completed Business Reply Form in the box with returned devices and affix the pre-paid authorized shipping label on product. Extra shipping labels may be obtained by calling 888-912-7090. Consignees with any questions can contact Ethicon Resource Department at 1-877-384-4266 from 8:00 AM to 5:00 PM EST from Monday through Friday.

Root cause

Device Design

Status

Open, Classified

Product code

GEI

Quantity affected

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 Netherl

Date initiated

2024-05-08

Date posted

2024-06-06

Location

Blue Ash, OH

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