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

FDA device recall Z-1947-2013 · posted 2013-08-13 · Terminated

Recall details

Recalling firm

Carefusion 2200 Inc

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.

Action taken

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. In addition, customers are requested to forward the Customer Acknowledgement Form, the Customer Notification Letter, the Certificate of Destruction Form, the Pictures of Location of Lot Numbers on Case/Product, and the Frequently Asked Questions (FAQs) to all end users which they have distributed the affected product. For questions call 847-473-7097.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

BTM

Quantity affected

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

Date initiated

2013-04-22

Date posted

2013-08-13

Date terminated

2015-06-16

Location

Waukegan, IL

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