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(HEALTH & SAFETY INSTITUDE) HSI CPR ISO-SHIELD (Made in USA) with key ring case

RONDEX PRODUCTS, INCORPORATED · Model Model 9550 · UDI-DI 00634376495506

510(k) clearances

Adverse events (10 deaths)

Recalls

Facilities

Description

The Rondex CPR ISO-SHIELD is a mouth-to-mask barrier device used to help a rescuer avoid direct contact with the patient when doing resuscitation. Large barrier surface area, 7" X 7" (17.5 cm X 17.5 cm), maximizes isolation between rescuer and patient. The barrier material is attached to a short bite block containing TWO (2) silicone valves which helps to isolate the patient's breath from the rescuer. The bite block helps to keep the barrier positioned correctly while keeping the patient's mouth open. This makes ventilations much easier when doing the head tilt/chin lift procedure. The short bite block, 2 cm in length reduces the risk of pushing the patient's tongue back and does not require a prescription Two grips extend away from the bite block to provide a means to help the rescuer hold the small bite bloc and also help release the barrier from the patient's face between resuscitation breaths. This device is for emergency use only and should only be used by persons properly trained in CPR and in the use of this device. ISO-SHIELD (TM) of Rondex Products, Inc. MADE IN USA

Recalls

Date	Firm	Reason
2016-05-16	Lifeline First Aid LLC	First aid kits or rescue kits are recalled because they contains the CPR Shield with One Way Valve and Barrier Filter (mask) and this mask is cleared only for prescription use and
2016-05-16	Lifeline First Aid LLC	Cadillac First Aid Kit is recalled because it contains the CPR Shield with One Way Valve and Barrier Filter (mask) and this mask is cleared only for prescription use and is not cle
2014-07-02	Dynarex Corporation	"THIS SIDE UP" is on the wrong side of the product. This error poses a potential health hazard if the wrong labeling is followed by caregivers.
2004-02-03	Rusch Inc	Valve cap may become loose and enter the air circuitry.
2004-02-03	Rusch Inc	Valve cap may become loose and enter the air circuitry.
2004-02-03	Rusch Inc	Valve cap may become loose and enter the air circuitry.
2004-02-03	Rusch Inc	Valve cap may become loose and enter the air circuitry.

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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.