Z-0518-2012

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

Name: Z-0518-2012 The IS Can Disposable CO2 absorber x 6 --- Carbon Dioxide absorbent for use on GE rebreathing systems...
Creator: Intersurgical Inc
Published: 2011-02-09
License: https://open.fda.gov/license/

Intersurgical Ltd. / initiated 2011-02-09 / Terminated / root cause: design

FDA source

Intersurgical Inc began a recall of The IS Can Disposable CO2 absorber x 6 --- Carbon Dioxide absorbent for use on GE rebreathing systems --- Manufactured in the United Kingdom for: Intersurgical... on 2011-02-09. The reason FDA records is "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". 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-0518-2012
Status: Terminated
Initiated: 2011-02-09
Posted: 2012-01-11
Terminated: 2013-01-15
Recalling firm: Intersurgical Ltd.
Product: 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.
Product code: BSF Absorber, Carbon-Dioxide
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.
Root cause tag: design
FDA root cause: Device Design
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.
Quantity in commerce: 110 units
Distribution: Worldwide Distribution- USA (nationwide) including the states of Florida, North Carolina, New York, Ohio, and the country of Canada.
Product codes and lots: 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).

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)