FDA Medical Device Recalls (openFDA)
Intersurgical Inc: 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.
- Recall number
- Z-0518-2012
- Recalling firm
- Intersurgical Inc
- 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.
- Status
- Terminated
- Initiated
- 2011-02-09
- Posted
- 2012-01-11
- Terminated
- 2013-01-15
- Reason
- 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
- 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
- 110 units
- Distribution
- Worldwide Distribution- USA (nationwide) including the states of Florida, North Carolina, New York, Ohio, and the country of Canada.
- Lot, serial or model codes
- 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).
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- BSF
- Firm FEI
- 1000120301
- Firm city
- Liverpool
- Firm state
- NY
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28