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Class I Medical Device Recall: GE Healthcare, LLC - Multi Absorber Original, Disposable - Model M1173310

Mon, 01/06/2014 - 12:00am
U.S. Food & Drug Administration

Recall Class: Class I

Date Recall Initiated: September 19, 2013

Product(s): GE Multi Absorber Original, Disposable

Model/catalog/lot numbers:
Model: M1173310
Lots: 12001 - 13031

Range of manufacturing and distribution dates:
Manufactured: August 2012 – May 2013
Distributed: August 2012 – July 2013

Use: The GE Healthcare Multi Absorber Original Disposable is a disposable product attachment that is used 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). These devices are used under constant supervision of a qualified healthcare professional during procedures where patients undergo general anesthesia. The Multi Absorber removes carbon dioxide as the patient exhales.

Recalling Firm:
GE Healthcare
Healthcare Systems
3000 N Grandview Blvd
Mail Stop: W450
Wauwatosa, Wisconsin 53188-1615

Reason for Recall: The Multi Asborber, Original may have a thin wall condition, which may lead to small holes in the water (drain) tube. This may result in loss of anesthetic gases, ventilations and oxygenation. This product may cause serious adverse health consequences, including death.

Public Contact: Customers with questions may contact, GE Healthcare Customer Service at 800-345-2700 (option 2, then option 4) Monday through Friday from 8:00 AM – 5:00 PM Eastern Time. Customers can also contact International Customer Service at +1-800-932-0760 (option 2) Monday through Friday from 8:00 AM to 5:00 PM Eastern Time.

FDA District: New Jersey District Office

FDA Comments:
On September 19, 2013, GE Healthcare notified affected customers of the problem by letter sent via FedEx overnight mail. The letter instructed customers to isolate all affected product, return any unused product in whole or partial cases and return the Urgent Medical Device Correction Confirmation that was attached by fax to 800-535-7923. Once the form is received, the customer will be contacted with replacement information. Customers were also asked to forward a copy of the notification letter to any healthcare facilities they had forwarded affected products to. Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Health care professionals and consumers may report adverse reactions or quality problems they experienced using these products to MedWatch: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.

Additional Links:

 

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