Recall Z-2250-2024— Megadyne Medical Products, Inc.

Name: FDA recall Z-2250-2024
Creator: U.S. Food and Drug Administration
Published: 2024-06-17

Class I · Ongoing

Class I FDA medical device recall by Megadyne Medical Products, Inc., initiated 2024-06-17. It names one FDA 510(k) clearance: K031285. Product: Brand Name: MEGADYNE" MEGA SOFT" Dual Reusable Patient Return Electrode Product Name: MEGADYNE" MEGA SOFT" Dual Reusable Patient Return Electrode Model/Catalog Number: 0835 Software Version: N/A Product Description: Reusable Patient Return Electrode, Mega Soft, Dual Cord, Adult, For Patients Weighing over 25lbs. (11.4kg), 117cm Long x 51cm Wide x 1.25cm Thick Component: No. Reason: To limit the use of the Mega Soft Pads to patients aged 12 or older to mitigate the potential risk of patient burns identified with use of Mega Soft pads..

Recalling firm: Megadyne Medical Products, Inc.
Classification: Class I
Status: Ongoing
Initiated: 2024-06-17
Firm location: Blue Ash, OH, United States

510(k) clearances named in this recall

1 on FDA's record

K031285 — MEGA 2000 SOFT DUAL CORD PATIENT RETURN ELECTRODE PADMegadyne Medical Products, Inc.·cleared 2003-05-19

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Brand Name: MEGADYNE" MEGA SOFT" Dual Reusable Patient Return Electrode Product Name: MEGADYNE" MEGA SOFT" Dual Reusable Patient Return Electrode Model/Catalog Number: 0835 Software Version: N/A Product Description: Reusable Patient Return Electrode, Mega Soft, Dual Cord, Adult, For Patients Weighing over 25lbs. (11.4kg), 117cm Long x 51cm Wide x 1.25cm Thick Component: No

Reason for recall

To limit the use of the Mega Soft Pads to patients aged 12 or older to mitigate the potential risk of patient burns identified with use of Mega Soft pads.

Data sourced from openFDA. This site is unofficial and independent of the FDA.