Spacelabs recalls anesthesia workstation absorbers due to potential switch failure
Spacelabs Healthcare is recalling CAS I/II Absorbers for Blease anesthesia workstations because the Bag-to-Vent switch may fail due to loose hardware.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA has classified this as a Class I recall, which indicates a reasonable probability that use of the product will cause serious adverse health consequences or death. Per the rubric, FDA Class I recalls are assigned a severity score of 4 or higher.
Plain-English summary
Spacelabs Healthcare Ltd. is recalling CAS I/II Absorbers and specific service kits that are parts of the BleaseSirius and BleaseFocus Anesthesia Workstations. The recall involves 37 units, with 19 located in the United States and 18 distributed internationally to countries including Libya, Finland, Jordan, Mexico, Papua New Guinea, and Taiwan.
The recall is being issued because the Bag-to-Vent switch in the CAS I/II Absorbers may fail due to loose fastening hardware within the absorber. These devices are intended for use in hospital environments and operating rooms by qualified physicians for the delivery of oxygen, air, nitrous oxide, and anesthetic vapor.
The FDA has classified this as a Class I recall. Users should contact Spacelabs Healthcare for instructions on how to address the defect in the affected units.
The recalled product
- 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…
- Manufacturer
- Del Mar Reynolds Medical, Ltd.
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
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