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XLR8 Abdominal Wound Dressing Kit

GENADYNE BIOTECHNOLOGIES INC. · Model A4-ABDO1-K · UDI-DI 00849405024101

OMP Prescription

510(k) clearances

9,182

Adverse events (75 deaths)

Recalls

100

Facilities

Description

XLR8 Abdominal wound dressing kit is indicated for use in conjuction with Genadyne NPWT System for patients who have open abdominal wounds with exposed viscera and organs, including but not limited to patients with abdominal compartment syndrome.

Recalls

Date	Firm	Reason
2025-01-17	KCI USA, INC.	Due to increase in complaints related to leak alarms
2024-11-05	KCI USA, INC.	Due to potential system error alarm and the inability to initiate therapy as a result of broken occlusion sensors.
2024-10-02	Smith & Nephew Medical, Ltd.	Due to issues with battery depletion and inability to recharge if the batteries are not appropriately maintained.
2024-03-11	Smith & Nephew Medical, Ltd.	Black particulate matter from the carbon filter component of the canisters entering the NPWT pump and potentially causing damage to the pump
2024-03-11	Smith & Nephew Medical, Ltd.	Black particulate matter from the carbon filter component of the canisters entering the NPWT pump and potentially causing damage to the pump
2020-06-08	KCI USA, INC.	The device may power off without notification to the user resulting in a stoppage of negative pressure wound therapy.
2020-06-04	Cardinal Health 200, LLC	Canisters potentially contain an oversized O-ring that cannot be installed into the mating connector on the device.
2020-06-04	Cardinal Health 200, LLC	Canisters potentially contain an oversized O-ring that cannot be installed into the mating connector on the device.
2019-12-02	Medela Inc	Invia Foam Dressing Kit with FitPad could have holes in the sterile packaging.
2018-02-07	Medela Inc	Device may display a battery missing error.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.