Reusable latex breathing bags with multiple part numbers and sold as part of test lung part number and reusable anaesthe

FDA device recall Z-1452-2014 · posted 2014-04-10 · Terminated

Recall details

Recalling firm

Draeger Medical, Inc.

Reason for recall

Reusable latex breathing bags with various part numbers and sold as part of test lung and reusable anaesthesia sets were recalled when Draeger became aware of an incident where a user suffered an acute allergic reaction after using a Drger latex test lung. The user did not suffer permanent injury. The breathing bag that belongs to the test lung and other latex breathing bags are labelled NR. A

Action taken

A recall notification letter, dated March 2014, was sent to wholesale distributors and end users.

Root cause

Labeling design

Status

Terminated

Product code

BZO

Quantity affected

433

Distribution

USA Nationwide Distribution in the states of: MI, SC, CO, OH, NE, WI, NC, SD, AZ, TX, MA, WA, PA, KY, MN, GA, OK, NY, IN, VA, UT, MT, ME,FL, CA, MD, MO, IA, TN, MD, WV, IL,NJ, CT, and AR.

Date initiated

2014-03-25

Date posted

2014-04-10

Date terminated

2014-10-08

Location

Telford, PA