FDAClass IIAugust 21, 2013

1) Adult Manual Resuscitator recall

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

Why was 1) Adult Manual Resuscitator 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

1) Product Code 2K8005; Lot Numbers: 0000355656, 0000355659, 0000355662, 0000355664, 0000355665, 0000355666, 0000355668; 2) Product Code 2K8004; Lot Number: 0000355673; 3) Product Code 2K8017; Lot Numbers: 0000355676, 0000355677; 4) Product Code 2K8034; Lot Number: 0000355688; 5) Product Code 2K8035; Lot Number: 0000358023; 6) Product Code 2K8037; Lot Number: 0000358025; 7) Product Code 2K8040; Lot Number: 0000358026

Product
1) Adult Manual Resuscitator, 2K8004, Oxygen Reservoir Bag, Adult Mask; 2) Adult Manual Resuscitator, 2K8005, 40" (1.0 m) Oxygen Reservoir Tubing…
Recalling firm
Carefusion 2200 Inc
Quantity
14,112 units
Distribution
US Nationwide in the states of AZ, CA, CO, DE, FL, GA, IL, LA, MA, MD, MI, MN, MO, MS, NC, NJ, NM, NY, OH, PA, TX, UT, WA
Recall date
August 21, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls