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U.S. Department of Health and Human Services

Class 2 Device Recall IS Can Disposable CO2 absorber

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 Class 2 Device Recall IS Can Disposable CO2 absorbersee related information
Date Initiated by FirmFebruary 09, 2011
Date PostedJanuary 11, 2012
Recall Status1 Terminated 3 on January 15, 2013
Recall NumberZ-0518-2012
Recall Event ID 60381
Product Classification Absorber, carbon-dioxide - Product Code BSF
ProductThe 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.
Code Information Product 2194: Lot numbers 1101240 (exp. date 2013-04), 1101425 (exp. date 2013-05), 1101426 (exp. date 2013-05), 1101902 (exp. date 2013-06); Product 2195: Lot numbers 1102927 (exp. date 2013-08), 1102596 (exp. date 2013-07), 1101423 (exp. date 2013-05), 1102596 (exp. date 2013-07); Product 2196: Lot numbers 1100392 (exp. date 2013-02), 1101241 (exp. date 2013-04), 1101426 (exp. date 2013-05), 1103379 (exp. date 2016-01); Product 2197: Lot numbers 1101281 (exp. date 2013-05), 1102597 (exp. date 2013-08); Product 2198: Lot numbers 1101107 (exp. date 2013-04), 1101427 (exp. date 2013-05), 1101428 (exp. date 2013-05).
FEI Number 1000120301
Recalling Firm/
Manufacturer		 Intersurgical Inc
417 Electronics Pkwy
Liverpool NY 13088
For Additional Information ContactMichael Zalewski
315-451-2900 Ext. 202
Manufacturer 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.
FDA Determined
Cause 2		Device Design
ActionIntersurgical 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.
Quantity in Commerce110 units
DistributionWorldwide Distribution- USA (nationwide) including the states of Florida, North Carolina, New York, Ohio, and the country of Canada.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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