—#122872

Product

Multi Absorber Original, Disposable M1173310 Multi Absorber Original, Disposable, package of 6 pcs, GE Healthcare Finland Oy Made in US Rx Only The GE Healthcare Multi Absorber Original, Disposable is a disposable product intended for use with the GE Healthcare Advanced Breathing System (later ABS), the GE Healthcare EZchange manifold, the GE Healthcare Compact Block, and the GE Healthcare Compact Block II (later Compact Block). The Multi Absorber should only be used with air, oxygen, nitrous oxide, halothane, enflurane, isoflurane, desflurane and sevoflurane. The device is intended to be used under constant attention of qualified professional healthcare personnel.

FDA product code: BSF — Absorber, Carbon-Dioxide
Device class: Class 1
Medical specialty: Anesthesiology
Affected lot / code info: product number M1173310 containing lot numbers 12001 through 13031.

Why it was recalled

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

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: GE Healthcare, LLC
Address: 3000 N Grandview Blvd, Waukesha, Wisconsin 53188-1615

Distribution

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

Timeline

Recall initiated: 2013-09-19
Posted by FDA: 2013-12-13
Terminated: 2015-03-10
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #122872. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.