Reported Nov 27, 2013 · Terminated

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

Del Mar Reynolds Medical, Ltd.

High riskUsing this product could cause serious injury, illness or death — stop using it now.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Del Mar Reynolds Medical, Ltd. · 1-2 Harforde Ct., Foxholes · Hertford · N/A

Is this the product you have?

CAS I/II Absorbers that are parts of the BleaseSirius Anesthesia Workstation, the BleaseFocus Anesthesia Workstation
with the following part numbers12200900; 12200901; 12200902; 12200903; 14200100, and service kits part number 050-0659-00 and 050-0901-00
BleaseFocus Anesthesia WorkstationThe 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 WorkstationThe 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

Lot codes and dates: 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
Amount recalled: 37 units (19 in the US and 18 International)

Where it was sold

Nationwide
NC
OK

Why it was recalled

Stop using this product now

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.

Using this product could cause serious injury, illness or death — stop using it now.

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