Z-1947-2013 Class II Terminated
FDA device recall Z-1947-2013 was initiated by Carefusion 2200 Inc on Apr 22, 2013 and is designated Class II. Reason for recall: 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… The recall status is terminated (terminated Jun 16, 2015). Affected quantity: 14,112 units.
Recall Details
- Product Type
- Devices
- Report Date
- Aug 21, 2013
- Initiation Date
- Apr 22, 2013
- Termination Date
- Jun 16, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 14,112 units
Product Description
1) Adult Manual Resuscitator, 2K8004, Oxygen Reservoir Bag, Adult Mask; 2) Adult Manual Resuscitator, 2K8005, 40" (1.0 m) Oxygen Reservoir Tubing, Adult Mask; 3) Adult Manual Resuscitator, 2K8017, Variable Volume Oxygen Reservoir Tubing, Adult Mask; 4) Adult Manual Resuscitator, 2K8034, 40" (1.0 m) Oxygen Reservoir Tubing, PEEP Valve, without Mask; 5) Adult Manual Resuscitator, 2K8035, Oxygen Reservoir Bag, PEEP Valve, Adult Mask; 6) Pediatric Manual Resuscitator, 2K8037, 40" (1.0 m) Oxygen Reservoir Tubing, PEEP Valve, Pediatric Mask, Pressure Limiting Valve with Lock; 7) Infant Manual Resuscitator, 2K8040, Oxygen Reservoir Bag, PEEP Valve, Infant Mask, Pressure Limiting Valve with Lock Product Usage: Pulmonary resuscitation
Reason for Recall
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.
Distribution Pattern
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
Code Information
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1947-2013
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026