The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-2683-2016·Announced 2016-09-07

Teleflex Recalls MAQUET Servo Humidifier 163 Units Due to Connector Cracking

Teleflex Medical is recalling 2,700 MAQUET Servo Humidifier 163 units because the ISO female connector may crack. The units were distributed to Florida, Kansas, and West Virginia.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall is classified as FDA Class II, which typically indicates a situation where use of the product could cause temporary or medically reversible adverse health consequences. The hazard involves a structural defect (cracking) in a medical device connector, which poses a risk of harm, but the source text does not report specific injuries or fatalities, placing it in the High severity category rather than Severe or Critical.

Plain-English summary

Teleflex Medical is recalling 2,700 units of the MAQUET Servo Humidifier 163. The recall was initiated because cracking may occur at the 15mm and 22mm ISO female connector. The affected units were manufactured by Inmed Mfg. Sdn. Bhd. in Malaysia.

The recalled products are identified by model number 01-06-8125-8, product code XKC01-06-8125-8, and lot numbers 201450, 201451, 201452, and 201504. These units were distributed in the United States to the states of Florida, Kansas, and West Virginia.

The FDA has classified this recall as Class II. Consumers and healthcare facilities should check their inventory for the specific model and lot numbers listed above. If the product is found, it should be removed from service and returned to Teleflex Medical according to the company's instructions.

The recalled product

Product
MAQUET Servo Humidifier 163, Inmed Mfg. Sdn. Bhd. Lot PT 2577, Jalan Perusahaan, 4, 34600 Kamunting, Perak, Malaysia.
Manufacturer
Teleflex Medical
Category
Medical Device — Respiratory Equipment
Hazard
Affected units
2,700

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (5)

  • Model number: 01-06-8125-8
  • Product code: XKC01-06-8125-8
  • Lot numbers: 201450
  • 201451
  • 201452 and 201504.

Distribution

Distributed in 3 states:

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