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Class 1 Device Recall BleaseSirius Anesthesia Workstation, BleaseFocus Anesthesia Workstation |
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Date Initiated by Firm |
October 17, 2013 |
Date Posted |
November 20, 2013 |
Recall Status1 |
Terminated 3 on April 24, 2014 |
Recall Number |
Z-0352-2014 |
Recall Event ID |
66721 |
510(K)Number |
K003251 K010850
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Product Classification |
Gas-machine, anesthesia - Product Code BSZ
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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 Anesthesia Workstation: The 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 Workstation: The 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.
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Code Information |
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. |
Recalling Firm/ Manufacturer |
Del Mar Reynolds Medical, Ltd. 1-2 Harforde Ct., Foxholes Business Park Hertford United Kingdom
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For Additional Information Contact |
800-522-7025
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Manufacturer 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.
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FDA Determined Cause 2 |
Process control |
Action |
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. |
Quantity in Commerce |
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. |
Total Product Life Cycle |
TPLC Device Report
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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510(K) Database |
510(K)s with Product Code = BSZ and Original Applicant = BLEASE MEDICAL EQUIPMENT LTD. 510(K)s with Product Code = BSZ and Original Applicant = ODIN MEDICAL TECHNOLOGIES LTD.
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