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Recall Observatory FDA recall evidence

Device product

REF 0562K (Adult Elongated O2/CO2 Mask - Product Usage: intended to connect with an oxygen source to deliver oxygen therapy to the patient.

Z-0745-2021

November 11, 2020

Class II

Product summary

Firm
Westmed, Inc.
Event
Event 86903
Status
Terminated
Classification
Class II
Quantity
16,000 units
Official record key
device-enforcement:Z-0745-2021

Official wording

Reason: 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 to the mask adapter resulting in a possible delay in treatment.

Code information: Lot # 081920N38 (Distributed outside US)

Distribution pattern: Worldwide distribution - US Nationwide distribution including in the states of PA, OK, MO, CO, RI, IL, CA, TX, OH, MD, IL, MN, KS and the countries of Canada, Korea, United Kingdom

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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 to the mask adapter resulting in a possible delay in treatment.