Multi Absorber Original, Disposable M1173310 Multi Absorber Original, Disposable, package of 6 pcs, GE Healthcare Finlan

FDA device recall Z-0472-2014 · posted 2013-12-13 · Terminated

Recall details

Recalling firm

GE Healthcare, LLC

Reason for recall

GE Healthcare has recently become aware of a potential safety issue due to air leakage associated with the CO2 Multi Absorber.

Action taken

GE issued an Urgent Medical Device Correction letter dated September 19, 2013, to all affected customers via Fed Ex overnight mail. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to not use the affected product, isolate all affected product and return the attached form via fax to 800-535-7923. Once the information is received, customers would be contacted with an RMA and replacement information. If product was distributed further the notice should be forwarded to those customers. For questions customers should call 1-800-345-2700, option 2 followed by ooption 2. For foreign customers 1-800-932-0760, option 2. For questions regarding this recall call 262-513-4122. GE issued a press release on 12/30/2013.

Root cause

Device Design

Status

Terminated

Product code

BSF

Quantity affected

US: 59,721 boxes, 358,326 canisters; OUS: 3,724 boxes, 22,344 canisters

Distribution

Worldwide Distribution - USA (nationwide) Puerto Rico and Internationally to Canada, Costa Rica, Mexico, and Venezuela.

Date initiated

2013-09-19

Date posted

2013-12-13

Date terminated

2015-03-10

Location

Waukesha, WI