The Recall Desk
Agency classClass IOur severity:SevereFDA (Devices)·Z-0968-2013·Announced 2013-03-27

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.

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 agency classified this recall as Class I — 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. On that classification alone this is scored Severe; a score of Critical is reserved for recalls where a death or serious injury was reported. The agency gives the reason as: "A defect in CAS I/II Absorbers in the Spacelabs Anesthesia Workstations and Service Kits may cause a condition leading to an increase in the carbon dioxide concentration within the inspired gas being delivered to the patient."

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.
Category
Medical Device — Anesthesia Workstation
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

Distributed nationwide across the United States.

The notice also names 2 states specifically:

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