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Penetrating Chest Injury Kit

H&H MEDICAL CORPORATION · Model 1 · UDI-DI 00857048006170

NAD

510(k) clearances

15,775

Adverse events (7 deaths)

Recalls

511

Facilities

Description

H&H Penetrating Chest Injury Kit, containing one Bolin Chest Seal and one Wound Seal Kit, for the treatment of entry and exit chest wounds to reduce the risk of tension pneumothorax.

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.