CLASS II Device recall · Reported 7 Sep 2016 · FDA Enforcement Report
Maquet Servo Humidifier 163, Inmed Mfg. Sdn recalled by Teleflex Medical
Teleflex Medical is recalling Maquet Servo Humidifier 163, Inmed Mfg. Sdn, distributed in Florida, Kansas, West Virginia. The recall was initiated on 3 Dec 2015 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-2683-2016
- FDA event ID
- 74793
- Recalling firm
- Teleflex Medical, Morrisville, NC
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 3 Dec 2015
- FDA classified
- 29 Aug 2016
- Reported
- 7 Sep 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Other Medical Devices
Timeline
| 3 Dec 2015 | Recall initiated by company | |
| 29 Aug 2016 | Classified by FDA | +270 days |
| 7 Sep 2016 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Cracking may occur at the 15mm and 22mm ISO female connector.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
MAQUET Servo Humidifier 163, Inmed Mfg. Sdn. Bhd. Lot PT 2577, Jalan Perusahaan, 4, 34600 Kamunting, Perak, Malaysia.
Where it was distributed
US Distribution to the states of : FL, KS, and WV.
Questions about this recall
Why was it recalled?
Cracking may occur at the 15mm and 22mm ISO female connector.
Which lots are affected?
Model number: 01-06-8125-8, Product code: XKC01-06-8125-8, Lot numbers: 201450, 201451, 201452 and 201504.
Where was it sold?
US Distribution to the states of : FL, KS, and WV.
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.
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