Reported Aug 21, 2013 · Terminated

1) Adult Manual Resuscitator, 2K8004, Oxygen Reservoir Bag, Adult Mask; 2) Adult Manual Resuscitator, 2K8005, 40" (1.0…

Carefusion 2200 Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Carefusion 2200 Inc · 1500 S Waukegan Rd · Waukegan, IL · 60085-6728

Is this the product you have?

10 of 10 products

Products covered by this recall
#Product as published
1Adult Manual Resuscitator, 2K8004, Oxygen Reservoir Bag, Adult Mask
2Adult Manual Resuscitator, 2K8005, 40" (1.0
3Oxygen Reservoir Tubing, Adult Mask
4Adult Manual Resuscitator, 2K8017, Variable Volume Oxygen Reservoir Tubing, Adult Mask
5Adult Manual Resuscitator, 2K8034, 40" (1.0
6Oxygen Reservoir Tubing, PEEP Valve, without Mask
7Adult Manual Resuscitator, 2K8035, Oxygen Reservoir Bag, PEEP Valve, Adult Mask
8Pediatric Manual Resuscitator, 2K8037, 40" (1.0
9Oxygen Reservoir Tubing, PEEP Valve, Pediatric Mask, Pressure Limiting Valve with Lock
10Infant Manual Resuscitator, 2K8040, Oxygen Reservoir Bag, PEEP Valve, Infant Mask, Pressure Limiting Valve with Lock Product Usage: Pulmonary resuscitation
Lot codes and dates

7 of 7 products

Products covered by this recall
Model / numberProduct as published
2K8005Lot Numbers: 0000355656, 0000355659, 0000355662, 0000355664, 0000355665, 0000355666, 0000355668
2K8004Lot Number: 0000355673
2K8017Lot Numbers: 0000355676, 0000355677
2K8034Lot Number: 0000355688
2K8035Lot Number: 0000358023
2K8037Lot Number: 0000358025
2K8040Lot Number: 0000358026
Amount recalled
14,112 units

Where it was sold

Why it was recalled

CareFusion has received four (4) customer reports of a component (oxygen connector) within the resuscitation bag being occluded which disables the flow of supplemental oxygen to the resuscitation bag and thus may pose a serious patient safety risk.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Jun 16, 2015 · Data as of Sep 19, 6:53 PM UTC

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