CLASS II Device recall · Reported 25 Apr 2018 · FDA Enforcement Report
Manometer three-Way Stopcock recalled by Carefusion 2200
Carefusion 2200 is recalling Manometer three-Way Stopcock, distributed nationwide in the US. The recall was initiated on 23 Feb 2017 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1421-2018
- FDA event ID
- 76620
- Recalling firm
- Carefusion 2200, Vernon Hills, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 Feb 2017
- FDA classified
- 18 Apr 2018
- Reported
- 25 Apr 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Other Medical Devices
Timeline
| 23 Feb 2017 | Recall initiated by company | |
| 18 Apr 2018 | Classified by FDA | +419 days |
| 25 Apr 2018 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The integrity of the sterile packaging is potentially compromised.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Manometer, 550 ml three-Way Stopcock; STERILE;
Where it was distributed
Nationwide, Australia, Brazil, Canada, China, Japan, Kuwait, Malaysia, Mexico, Netherlands, New Zealand, Philippines, Singapore, South Africa, Taiwan, Thailand, United Arab Emirates, Vietnam
Questions about this recall
Is Manometer three-Way Stopcock recalled?
Yes. Carefusion 2200 recalled Manometer three-Way Stopcock on 23 Feb 2017. The recall is Class II and its status is Terminated. Recall number Z-1421-2018.
Why was it recalled?
The integrity of the sterile packaging is potentially compromised.
Which lots are affected?
Product Code: 4330 Lot Code: 0000837810; 0000840335; 0000842213; 0000848531; 0000851181; 0000853962
Where was it sold?
Nationwide, Australia, Brazil, Canada, China, Japan, Kuwait, Malaysia, Mexico, Netherlands, New Zealand, Philippines, Singapore, South Africa, Taiwan, Thailand, United Arab Emirates, Vietnam
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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