Z-0472-2014Class I

Multi Absorber Original, Disposable M1173310 Multi Absorber Original, Disposable, package of 6 pcs, GE...

Name: Z-0472-2014 Multi Absorber Original, Disposable M1173310 Multi Absorber Original, Disposable, package of 6 pcs, GE...
Creator: GE Healthcare, LLC
Published: 2013-09-19
License: https://open.fda.gov/license/

GE Healthcare / initiated 2013-09-19 / Terminated / root cause: design

FDA source

GE Healthcare, LLC began a recall of Multi Absorber Original, Disposable M1173310 Multi Absorber Original, Disposable, package of 6 pcs, GE Healthcare Finland Oy Made in US Rx Only The GE... on 2013-09-19. FDA classified it as Class I and gives the reason as "GE Healthcare has recently become aware of a potential safety issue due to air leakage associated with the CO2 Multi Absorber". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0472-2014
Classification: Class I
Status: Terminated
Initiated: 2013-09-19
Posted: 2013-12-13
Terminated: 2015-03-10
Recalling firm: GE Healthcare
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.
Product code: BSF Absorber, Carbon-Dioxide
Reason for recall: GE Healthcare has recently become aware of a potential safety issue due to air leakage associated with the CO2 Multi Absorber.
Root cause tag: design
FDA root cause: Device Design
Action: 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.
Quantity in commerce: 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.
Product codes and lots: product number M1173310 containing lot numbers 12001 through 13031.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0472-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0472-2014	Class I	Terminated	Voluntary: Firm initiated	2013-12-25	2013-12-13

Product code BSF

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)