BagEasy manual resuscitation devices are used for patients… recallZ-2332-2010 · Westmed Inc · initiated Jun 22, 2010
Terminated All recalls posted in September 2010
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Westmed Inc or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Nonconforming Material/Component
What the company is doing
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.
Recall details
- Recall number
- Z-2332-2010
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Jun 22, 2010
- Posted by the FDA
- Sep 8, 2010
- Recalling firm
- Westmed Inc
- Quantity
- 22145
- Product code
- BTM
- FDA submissions
- K934310, K940581
- Distribution
- Worldwide distribution.
Product description
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.
Code information (models, lots, serial numbers)
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
Other devices under the same FDA submission
1 device cleared under K934310, K940581 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- BagEasy 562048Westmed, Inc. · Ventilator, Emergency, Manual (Resuscitator)1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 56162).
- Z-2333-2010 · TerminatedBagEasy manual resuscitation devices are used for patients requiring complete or intermittent ventilatory support. It can provide positive pressure ventilation or oxygen for the s…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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