FDA Medical Device Recalls (openFDA)
Westmed Inc: 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.
- Recall number
- Z-2333-2010
- 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.
- Status
- Terminated
- Initiated
- 2010-06-22
- Posted
- 2010-09-08
- Terminated
- 2011-03-22
- Reason
- 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
- 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 kpeterson@westmedinc.com 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
- 2,734
- Distribution
- Worldwide distribution.
- Lot, serial or model codes
- 510K # for Child/Infant product: K940581 Part#: 562080 - Lot#:48719, 49144 Part#: 562081 - Lot#:49643, 49660 Part#: 562082 - Lot#: 48091, 49274, 49386, 49487 Part#: 562084 - Lot#: 48119, 48578, 48733, 48941, 49042, 49254 Part#: 562086 - Lot#: 47895, 48071, 48488, 48823 Part#: 562110 - Lot#: 49489 Part#: 562111 - Lot#: 49611, 48276 Part#: 32628- Lot#: 49273, 49273, 47834 Part#: 32629 - Lot#: 48140, 48141, 48428, 48142, 48275, 48652, 48429
- 510(k) numbers
- ["K934310","K940581"]
- PMA numbers
- not on file
- Product code
- BTM
- Firm FEI
- 1000374126
- Firm city
- Tucson
- Firm state
- AZ
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28