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

FDA device recall Z-0352-2014 · posted 2013-11-20 · Terminated

Recall details

Recalling firm

Del Mar Reynolds Medical, Ltd.

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.

Action taken

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.

Root cause

Process control

Status

Terminated

Product code

BSZ

Quantity affected

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.

Date initiated

2013-10-17

Date posted

2013-11-20

Date terminated

2014-04-24

Location

Hertford, United Kingdom

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