Z-0352-2014Class I

CAS I/II Absorbers that are parts of the BleaseSirius Anesthesia Workstation, the BleaseFocus Anesthesia...

Name: Z-0352-2014 CAS I/II Absorbers that are parts of the BleaseSirius Anesthesia Workstation, the BleaseFocus Anesthesia...
Creator: Del Mar Reynolds Medical, Ltd.
Published: 2013-10-17
License: https://open.fda.gov/license/

GE Healthcare / initiated 2013-10-17 / Terminated / root cause: manufacturing process

FDA source

Del Mar Reynolds Medical, Ltd. began a recall of CAS I/II Absorbers that are parts of the BleaseSirius Anesthesia Workstation, the BleaseFocus Anesthesia Workstation with the following part numbers: 12200900... on 2013-10-17. FDA classified it as Class I and gives the reason as "Spacelabs Healthcare Ltd. of United Kingdom recalls , and Service Kits, Part Number 050-0659-00 and 050-0901-00. The Bag to-Vent switch in CAS I/II Absorbers may fail due to loose fastening hardware in an absorber". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0352-2014
Classification: Class I
Status: Terminated
Initiated: 2013-10-17
Posted: 2013-11-20
Terminated: 2014-04-24
Recalling firm: GE Healthcare
Product: CAS I/II Absorbers that are parts of the BleaseSirius Anesthesia Workstation, the BleaseFocus Anesthesia Workstation with the following part numbers: 12200900; 12200901; 12200902; 12200903; 14200100, and service kits part number 050-0659-00 and 050-0901-00. BleaseFocus Anesthesia Workstation: The Blease Frontline Plus Range, Anesthesia Machines are intended for use in the hospital environment and locations not requiring portability. It may be used for the delivery of oxygen, air and nitrous oxide in a controlled manner to various patient breathing circuits with or without the use of a mechanical ventilator, and may be used for the delivery of anesthetic vapor by use of a dismountable vaporizer. This device is intended for use only by a suitably qualified physician. BleaseSirius Anesthesia Workstation: The Spacelabs BleaseSirius Anesthesia Workstation is intended for use in the hospital environment and operating room. It may be used for the delivery of oxygen, air and nitrous oxide in a controlled manner to various patient breathing circuits with or without the use of mechanical ventilator, and may be used for the delivery of anesthetic vapor by use of a dismountable vaporizer. The device is intended for use only by a suitably qualified physician.
Product code: BSZ Gas-Machine, Anesthesia
Reason for recall: Spacelabs Healthcare Ltd. of United Kingdom recalls , and Service Kits, Part Number 050-0659-00 and 050-0901-00. The Bag to-Vent switch in CAS I/II Absorbers may fail due to loose fastening hardware in an absorber.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Spacelabs Healthcare sent an Urgent Medical Device Correction letter dated November 1, 2013, to all affected customers. Spacelabs Healthcare also sent a customer letter (translated as necessary) to all international subsidiaries and distributors of record via e-mail on November 6, 2013. The letter informed customers of a potential defect in CAS I/II Absorber products employed in the Spacelabs Healthcare BleaseSirius Anesthesia Workstation, and Service Kits, Part Number 050-0659-00 and 050-0901-00. The Bag-to-Vent switch in CAS I/II Absorbers may fail. In the worst case, this would result in a large leak from the absorber circuit and could impede the ability to provide ventilation. Customers were instructed to immediately advise their staff of the problem. Customers with questions were instructed to contact Spacelabs Healthcare at 1-800-522-7025 and select 2 for Technical Support. For questions regarding this recall call 800-522-7025.
Quantity in commerce: 37 units (19 in the US and 18 International)
Distribution: Worldwide Distribution - USA (nationwide) including Oklahoma and North Carolina and Internationally to Libyan Arab Jamahiriya, Finland, Jordan, Mexico, Papua New Guinea, and Taiwan.
Product codes and lots: SERIAL NUMBERS IN THE US: ABSO-001754, ABSO-004081, ABSO-100111, ABSO-100112, ABSO-100113, ABSO-100114, ABSO-100117, ABSO-100120, ABSO-100121, ABSO-100122, ABSO-100123, ABSO-100124, ABSO-100125, ABSO-100126, ABSO-100127, ABSO-100128, ABSO-100132, ABSO-100134, and ABSO-100135. SERIAL NUMBERS INTERNATIONAL: ABSO-100098, ABSO-100099, abso-100100, ABSO-100101, abso-100102, ABSO-100103, abso-100104, abso-100105, abso-100106, ABSO-100107, ABSO-100108, ABSO-100109, ABSO-100110, ABSO-100129, ABSO-100130, ABSO-100131, ABSO-100136, AND ABSO-100137.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0352-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0352-2014	Class I	Terminated	Voluntary: Firm initiated	2013-11-27	2013-11-20

Product code BSZ

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)