CriticalClass ITerminated

FDA Devices recall · Reported November 27, 2013

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

Q: Which agency issued this recall?

This recall was issued by the FDA Devices on November 27, 2013. Severity: Critical. Recall number: Z-0352-2014.

Q: Where was the recalled product distributed?

Distribution: Worldwide Distribution - USA (nationwide) including Oklahoma and North Carolina and Internationally to Libyan Arab Jamahiriya, Finland, Jordan, Mexico, Papua New Guinea, and Taiwan..

Q: How do I check if my product is affected by a recall?

Check the product description and recall number (Z-0352-2014) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.

Q: Should I stop using a recalled medication or medical device?

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

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 loos…

Recall #: Z-0352-2014
Affected scope: 37 units (19 in the US and 18 International)
Initiated: October 17, 2013

Compiled from official public sources by the editorial team. · Updated July 2026

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Del Mar Reynolds Medical, Ltd. recalled CAS I/II Absorbers that are parts of the BleaseSirius Anesthesia Workstation, the BleaseF… - a critical-severity action.

CAS I/II Absorbers that are parts of the BleaseSirius Anesthesia Workstation, the BleaseF… was recalled by Del Mar Reynolds Medical, Ltd. in November 27, 2013. Reason: Spacelabs Healthcare Ltd. of United Kingdom recalls , and Service Kits, Part Number 050-0659-00 and 050-0901-…. Check the official notice for the remedy. Verify recall #Z-0352-2014 with the FDA Devices before acting.

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The recall

Del Mar Reynolds Medical, Ltd. issued this critical-severity FDA Devices recall-Spacelabs Healthcare Ltd. of United Kingdom recalls , and Service Kits, Part Number 050-0659-00 and 050-0901-….

Critical
severity level: 37 units
affected scope: Class I
classification: November 27, 2013
reported

Sourced from official FDA Devices enforcement records. Verify recall #Z-0352-2014 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This FDA Devices action (record #Z-0352-2014) was formally reported on November 27, 2013, with the manufacturer initiating the action on October 17, 2013. It is classified under Critical severity (Class I), with a current status of Terminated. Del Mar Reynolds Medical, Ltd. is listed as the recalling firm, operating out of Hertford. Federal records list the affected scope as 37 units (19 in the US and 18 International).

The documented reason for this recall is: 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. Distribution data in the federal record shows the product reached: Worldwide Distribution - USA (nationwide) including Oklahoma and North Carolina and Internationally to Libyan Arab Jamahiriya, Finland, Jordan, Mexico, Papua New Guinea, and Taiwan.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Where this recall sits in the database

Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Severity

Critical

Affected scope

37 units (19 in the US and 18 International)

Related Recalls

3 from same agency

Product description

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.

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.

Recall Profile

Structured summary of the FDA Devices recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Critical (Class I)
Status	Terminated
Recall number	Z-0352-2014
Date reported	November 27, 2013
Date initiated	October 17, 2013
Recalling firm	Del Mar Reynolds Medical, Ltd.
Firm location	Hertford
Affected scope	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.

Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

37 units (19 in the US and 18 International) units affected - limited or regional distribution scale.

Regional (<10K units) ✓ This recall

Multi-state (10K – 100K units) -

Large-scale (100K – 1M units) -

Massive (≥1M units) -

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

Check the recall number (Z-0352-2014) and product description against the item you own. Search the archive
Confirm the current status with FDA Devices before acting, recall details can be updated.
This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next

This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled? ▼

Why was this product recalled? ▼

Which agency issued this recall? ▼

This recall was issued by the FDA Devices on November 27, 2013. Severity: Critical. Recall number: Z-0352-2014.

Where was the recalled product distributed? ▼

Distribution: Worldwide Distribution - USA (nationwide) including Oklahoma and North Carolina and Internationally to Libyan Arab Jamahiriya, Finland, Jordan, Mexico, Papua New Guinea, and Taiwan..

How do I check if my product is affected by a recall? ▼

Check the product description and recall number (Z-0352-2014) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.

Should I stop using a recalled medication or medical device? ▼

Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported November 27, 2013. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.