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Terminated

The IS Can Disposable CO2 absorber x 6 --- Carbon Dioxide absorbent for use on GE rebreathing systems --- Manufactured in the United Kingdom for: Intersurgical Incorporated --- 417 Electronics Parkway, Liverpool, NY 13088. Intended use: GE Healthcare anesthetic machines: S5 Aespire, S5 Avance, Aisys. The Intersurgical IS Can is for use with air, oxygen, nitrous oxide, halothane, enflurane, isoflurane, desflurane and sevoflurane.

FDA Recall Z-0518-2012 · Posted 2012-01-11

Recalling FirmIntersurgical Inc
Recall StatusTerminated
Product CodeBSF
Date Initiated2011-02-09
Date Terminated2013-01-15
Product Quantity110 units

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.

Firm Action

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

Distribution Pattern

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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