RENASYS EDGE The RENASYS EDGE pump is indicated for patients who would benefit from a suction pump (NPWT), as it may pro

FDA device recall Z-0516-2025 · posted 2024-11-22 · Open, Classified

Recall details

Recalling firm

Smith & Nephew Medical, Ltd.

Reason for recall

Due to issues with battery depletion and inability to recharge if the batteries are not appropriately maintained.

Action taken

On 10/02/2024, the firm sent via overnight mail an "Urgent Medical Device Correction Notice" to customers informing them of an issue associated with the RENASYS EDGE batteries if not appropriately maintained and charged, the batteries may become depleted and be unable to recharge. Customers are instructed to: 1. Please inspect your inventory and locate any RENASYS. EDGE devices from the listed product and serial numbers enclosed with this Urgent Medical Device Correction Notice, and quarantine them immediately. a. If you are a sales rep, please work with sales leadership to have device upgraded or returned. b. If you are a distributor/DME, your Care Continuum Director will contact you with next steps once you submit the completed Acknowledgment Form. Note: Based on the regulatory classification and degree of hazard, this field action extends to the retail level. Therefore, it is not required to communicate this notice to the patient at the consumer level. 2. Complete Correction Acknowledgement Form and submit to fieldactions@smith-nephew.com. Firm's contact information: Smith & Nephew, Inc. Global Field Actions 1450 E Brooks Road Memphis, TN 38116 www.smith-nephew.com T: + 1 901 396 2121 T: 1 800 821 5700 (USA toll free)

Root cause

Process control

Status

Open, Classified

Product code

OMP

Quantity affected

1589 units

Distribution

U.S.: AL, CA, CO, FL, HI, IN, KY, NE, NY, PA, SC, TN and WI O.U.S.: Canada

Date initiated

2024-10-02

Date posted

2024-11-22

Location

Hull, United Kingdom

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