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Pocket Mask, PB (DE FR ES IT EN)

Laerdal Medical AS · Model 82002133 · UDI-DI 07045432118124

KGB CBP

510(k) clearances

165

Adverse events (6 deaths)

Recalls

151

Facilities

Description

The Laerdal Pocket Mask is designed for mouth-to-mask ventilation of a non-breathing adult, child or infant as a barrier between the rescuer and patient. For use on an infant, the mask may be turned 180° to achieve a better seal.

Recalls

Date	Firm	Reason
2020-11-11	Westmed, Inc.	There is a potential that the fitment between the oxygen delivery tube and the mask adapter may become loose. This could result in the device tubing not making a secure connection
2020-11-11	Westmed, Inc.	There is a potential that the fitment between the oxygen delivery tube and the mask adapter may become loose. This could result in the device tubing not making a secure connection
2020-11-11	Westmed, Inc.	There is a potential that the fitment between the oxygen delivery tube and the mask adapter may become loose. This could result in the device tubing not making a secure connection
2020-11-11	Westmed, Inc.	There is a potential that the fitment between the oxygen delivery tube and the mask adapter may become loose. This could result in the device tubing not making a secure connection
2020-11-11	Westmed, Inc.	There is a potential that the fitment between the oxygen delivery tube and the mask adapter may become loose. This could result in the device tubing not making a secure connection
2020-11-11	Westmed, Inc.	There is a potential that the fitment between the oxygen delivery tube and the mask adapter may become loose. This could result in the device tubing not making a secure connection
2004-07-12	Medex Inc	The non-rebreathing masks and watertraps were manufactured with natural rubber or rubber by-products and were not labeled appropriately as containinig latex.
2004-07-12	Medex Inc	The non-rebreathing masks and watertraps were manufactured with natural rubber or rubber by-products and were not labeled appropriately as containinig latex.

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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.