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Russell Chest Seal (US Version)

SAFEGUARD MEDICAL TECHNOLOGIES LIMITED · Model PDF0680 · UDI-DI 05060483570365

NAD Prescription

510(k) clearances

20,424

Adverse events (7 deaths)

Recalls

521

Facilities

Description

The Russell Chest Seal® is a hydrogel-based dressing with an integral low-profile, four apertures, valve. The base material of the chest seal is a hydrogel matrix, which comprises a water-containing gel, mounted onto a non-woven fabric with silicon coated release liners. The Russell Chest Seal® is used to cover penetrating chest wounds, and the valve mechanism allows air to escape from the pleural cavity without being drawn back in. This aims to minimise lunge collapse associated with this injury and to facilitate lung re-inflation. The device will remain adhered over many hours and is comfortable for the patient in prolonged use (up to 24 hours).

Recalls

Date	Firm	Reason
2025-08-29	ConvaTec, Inc	Wound dressing may have foreign matter on the product.
2025-02-19	MEDLINE INDUSTRIES, LP - Northfield	There is a potential for the sterility of the device to be compromised.
2022-01-28	Sam Medical Products	Due to partially assembled valved dressing that has a hole within it instead of the intended non-valved dressing in the package resulting in that the dressing cannot be centered ov
2021-08-20	ConvaTec, Inc	Primary packaging labeling may be incorrect.
2021-08-09	ConvaTec, Inc	There is a potential for open seals which can compromise sterility.
2018-08-01	COVIDIEN LLC	Potential for product sterility breach due to a compromised or pinched seal defect
2018-08-01	COVIDIEN LLC	Potential for product sterility breach due to a compromised or pinched seal defect
2018-08-01	COVIDIEN LLC	Potential for product sterility breach due to a compromised or pinched seal defect
2018-08-01	COVIDIEN LLC	Potential for product sterility breach due to a compromised or pinched seal defect
2018-08-01	COVIDIEN LLC	Potential for product sterility breach due to a compromised or pinched seal defect

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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.