Home / Recalls / Westmed, Inc. / Z-0744-2021

Z-0744-2021 Class II Terminated

Recalled by Westmed, Inc. — Tucson, AZ

Recall Details

Product Type
Devices
Report Date
January 6, 2021
Initiation Date
November 11, 2020
Termination Date
February 7, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1200 units

Product Description

REF 0562F, Adult CO2/O2 Mask, 10'X0.50 GSL w/ Swivel Elbow, 2" Pigtail w/Female Luer Connectors, 7' Oxygen Supply Tubing, 0.8 Micron Filter, Rx Only, CE0482, (01)00709078005664 - Product Usage: intended to connect with an oxygen source to deliver oxygen therapy to the patient.

Reason for Recall

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.

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

Code Information

Lot # 091720N71 (Distributed outside US)

Other recalls by Westmed, Inc.

  • Z-0263-2025 Class II — 1) Flex Extenders, 5.2" x 15mm OD x 15mm ID REF S6411P 2) Flex Extender, 5.2" (September 27, 2024)
  • Z-0745-2021 Class II — REF 0562K (Adult Elongated O2/CO2 Mask - Product Usage: intended to connect with (November 11, 2020)
  • Z-0746-2021 Class II — REF 0562, Adult Elongated O2/CO2 Mask, 10'X0.50 GSL w/ Swivel Elbow, 2" Pigtail (November 11, 2020)
  • Z-0742-2021 Class II — Westmed DISPOSABLE RESPIRATORY PRODUCTS NON-REBREATHER MASK, REF 3228-e, RX Onl (November 11, 2020)
  • Z-0741-2021 Class II — REF 3102-E, Elongated Oxygen Mask, Adult Oxygen Elongated Mask with 8' Tubing, R (November 11, 2020)
  • Z-0743-2021 Class II — REF 0930 Adult Elongated CO2/O2 Mask, 7' Tubing w/ Threaded Nut, Sivel GSE, 10' (November 11, 2020)
  • Z-2436-2020 Class II — Neo-Vent Infant T-Piece Resuscitation Circuit With Neonatal Mask; Circuit for us (January 15, 2019)
  • Z-2434-2020 Class II — Neo-Vent Infant T-Piece Resuscitation Circuit;Circuit for use on compatible Infa (January 15, 2019)
  • Z-2435-2020 Class II — Neo-Vent Infant T-Piece Resuscitation Circuit With Infant Mask; Circuit for use (January 15, 2019)
  • Z-0106-2013 Class II — Pulset Arterial Blood Gas (ABG) sampling kit. Full Kit, Pulset, 3 cc, 23g x 1 (January 18, 2011)