Spacelabs Anesthesia Workstation Recall for Carbon Dioxide Defect
Del Mar Reynolds Medical is recalling Spacelabs anesthesia workstations and service kits containing CAS I/II Absorbers due to a defect that may increase carbon dioxide levels in patient gas.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a medical device defect that may lead to increased carbon dioxide levels in patients, representing a risk of harm where specific injury reports are not detailed in the source text, fitting the 'High' severity criteria for risk-of-harm products.
Plain-English summary
Del Mar Reynolds Medical, Ltd. is recalling specific Spacelabs BleaseSirius and BleaseFocus Anesthesia Workstations, as well as Service Kits containing the CAS I/II Absorber. The recall affects 108 total units, including 17 units in the United States and 91 units outside the US. Distribution includes the US states of New Mexico and North Carolina, as well as Argentina, China, Mexico, and Taiwan.
The recall is due to a defect in the CAS I/II Absorbers that may cause an increase in the carbon dioxide concentration within the inspired gas delivered to the patient. This defect poses a risk to patient safety during anesthesia administration.
Healthcare facilities and users should identify affected units by checking the serial numbers listed in the official FDA recall notice. The firm has provided updated serial number lists to correct previous data entry errors. Users should contact Del Mar Reynolds Medical for instructions on replacing the nonconforming absorbers with conforming parts.
The recalled product
- Product
- Spacelabs BleaseSirius Anesthesia Workstation, BleaseFocus Anesthesia Workstation, and CAS I/II Absorber contained in Service Kits Part Number 12200902, 050-0659-00 and 050-0901-00 and any workstation installed with the CAS I/II Absorber. Anesthesia workstation for use in
- Manufacturer
- Del Mar Reynolds Medical, Ltd.
- Hazard
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: ABSO-004448
- ABSO-004458
- ABSO-004459
- ABSO-004460
- ABSO-004461
- ABSO-004462
- ABSO-004463
- ABSO-004465
- ABSO-004466
- ABSO-004467
- ABSO-004468
- ABSO-004469
- ABSO-004470
- ABSO-004471
- ABSO-004472
- ABSO-004473
- ABSO-004474
- ABSO-004475
- ABSO-004476
- ABSO-004477
Distribution
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