Recall Z-1947-2013 ยท BTM Ventilator, Emergency, Manual (Resuscitator)
Carefusion 2200 Inc
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
| Date | Aug 13, 2013 (initiated Apr 22, 2013) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Nonconforming Material/Component |
| Action | CareFusion sent an URGENT RECALL NOTICE letter dated April 22, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers are requested to complete and return an attached Distributor Acknowledgement Form within fifteen (15) days of receipt indicating their acknowledgement of the URGENT RECALL NOTICE and indicate if they have any affected product on hand. They are further requested to perform a 100% physical inventory to verify if any of the affected product codes/lot numbers are in stock within their distribution network/facility. |
| 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K924610 | BAXTER ADULT/PEDI/INFANT SINGLE USE MAN RESUSCIT Engineered Medical Systems, Apr 6, 1993 |