CLASS II Device recall · Reported 9 Apr 2014 · FDA Enforcement Report
Pressure Monitoring Tubing, PM6006 recalled by Merit Medical Systems
Merit Medical Systems is recalling Pressure Monitoring Tubing, PM6006, distributed nationwide in the US. The recall was initiated on 13 Mar 2014 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-1319-2014
- FDA event ID
- 67844
- Recalling firm
- Merit Medical Systems, South Jordan, UT
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 13 Mar 2014
- FDA classified
- 3 Apr 2014
- Reported
- 9 Apr 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Device type
- Patient Monitors
Timeline
| 13 Mar 2014 | Recall initiated by company | |
| 3 Apr 2014 | Classified by FDA | +21 days |
| 9 Apr 2014 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The products are labeled as sterile but were not sterilized.
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
Pressure Monitoring Tubing, PM6006. Pressure Monitoring Tubing (PM series) is used between the manifold and transducer as a conduit to transmit the fluid pressure of the patient to the pressure transducer.
Where it was distributed
Worldwide Distribution - USA Nationwide in the state of WI and countries of Thailand and Hong Kong.
Questions about this recall
Why was it recalled?
The products are labeled as sterile but were not sterilized.
Which lots are affected?
Lot Number H591335
Where was it sold?
Worldwide Distribution - USA Nationwide in the state of WI and countries of Thailand and Hong Kong.
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 67844This product is part of a recall event; the main page for the event is Merit Custom Syringe Kit, Convenience Kit, I.R recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Merit Custom Syringe Kit, Convenience Kit, I.R recalled | Merit Medical Systems | Sterility | Nationwide |
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|---|---|---|---|---|---|
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| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | Lux-Dx, Lux-Dx II, Lux-Dx II+ Insertable Cardiac Monitor recalled | Boston Scientific | Device Malfunction | Nationwide |
| Device | CLASS II | IQecg Digital ECG recalled by Midmark | Midmark | Labeling Errors | Nationwide |