The IS Can Disposable CO2 absorber x 6 --- Carbon Dioxide absorbent for use on GE rebreathing systems --- Manufactured i

FDA device recall Z-0518-2012 · posted 2012-01-11 · Terminated

Recall details

Recalling firm

Intersurgical Inc

Reason for recall

Intersurgical Incorporated has issued a voluntary recall of the IS Cans Carbon Dioxide Absorber due to a possibility that loose granules may enter the inspiratory path of the breathing system.

Action taken

Intersurgical Inc. sent an "URGENT MEDICAL DEVICE RECALL" letter dated February 8, 2011 to all affected customers. The letter described the product, problem, and actions to be taken by the customers. The letter instructs customers to immediately discontinue use and quarantine any affected product found. A Recall Response Form was attached to the letter for customers to complete and return via fax at 315-451-3696, Attn: Customer Service. Contact Customer Service at 1-800-828-9633 if you have questions concerning this recall.

Root cause

Device Design

Status

Terminated

Product code

BSF

Quantity affected

110 units

Distribution

Worldwide Distribution- USA (nationwide) including the states of Florida, North Carolina, New York, Ohio, and the country of Canada.

Date initiated

2011-02-09

Date posted

2012-01-11

Date terminated

2013-01-15

Location

Liverpool, NY