Z-2332-2010

BagEasy manual resuscitation devices are used for patients requiring complete or intermittent ventilatory...

Name: Z-2332-2010 BagEasy manual resuscitation devices are used for patients requiring complete or intermittent ventilatory...
Creator: Westmed Inc
Published: 2010-06-22
License: https://open.fda.gov/license/

Westmed Inc / initiated 2010-06-22 / Terminated / root cause: manufacturing process

FDA source

Westmed Inc began a recall of BagEasy manual resuscitation devices are used for patients requiring complete or intermittent ventilatory support. It can provide positive pressure ventilation... on 2010-06-22. The reason FDA records is "This recall was initiated after Westmed, Inc. became aware of a potential for disconnection at the patient port retention ring assembly of the Bag Easy manual resuscitation device". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2332-2010
Status: Terminated
Initiated: 2010-06-22
Posted: 2010-09-08
Terminated: 2011-03-22
Recalling firm: Westmed Inc
Product: BagEasy manual resuscitation devices are used for patients requiring complete or intermittent ventilatory support. It can provide positive pressure ventilation or oxygen for the spontaneously breathing patient with a face mask or through an artificial airway. A manual emergency ventilator is a device, incorporating a bag and valve, intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway.
Product code: BTM Ventilator, Emergency, Manual (Resuscitator)
Reason for recall: This recall was initiated after Westmed, Inc. became aware of a potential for disconnection at the patient port retention ring assembly of the Bag Easy manual resuscitation device.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm, Westmed, sent a letter dated June 21, 2010, to all customers. The letter describes the product, problem and action to be taken by customer. The customers were instructed to cease distribution immediately, notify any facilities that they may have distributed the product identified of the recall, call Customer Service Manager at 1-800-975-7987 x 1223 and/or email [email protected] to receive Return Authorization to return identified product, and complete and return the enclosed Bag Easy Recall Reconciliation Checklist. If you have any question, contact Customer Service at 1-800-975-7987 or 1-520-294-7987.
Quantity in commerce: 22145
Distribution: Worldwide distribution.
Product codes and lots: 510K # for Adult product: K934310 Part Number: 562013: Lot #47952, 48174, 48320, 48489, 48718, 48893, 49093, 49179, 49353, 49567, 49685 Part Number: 562048: Lot#47772, 47896, 47971, 47972, 48319, 48449, 48577, 48892, 48970, 49092, 49178 Part Number: 562133: Lot# 48321, 49225 49407 Part Number: 562136: Lot#47728, 49094 49275

Product code BTM

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)