Serious riskFDA DeviceClass I

Draeger Vapor 3000 vaporizers recalled for component impurities

Draeger, Inc. is recalling certain Vapor 3000 anesthetic vaporizers (Model M36500) because a component inside was not built to specification and contains impurities. This affects 188 units with specific serial numbers distributed worldwide. No injuries have been reported.

From the FDA notice · Read the official notice ↗ · All Draeger recalls

What to do

  1. Check if your device serial number matches the affected list (ASUK-0241 through ASUK-1620)
  2. Contact Draeger, Inc. immediately if your vaporizer is affected
  3. Do not use the device until you confirm it is not on the recall list
  4. Follow Draeger's instructions for inspection, repair, or replacement

Is yours affected?

Compare your label or packaging with the recalled product.

Product
Draeger Vapor 3000. Unheated, calibrated anesthetic vaporizer.
Sold in
Nationwide
Made for
All ages (under 100 years)

This recall covers 2 products — see all of them.

Details

Units affected
188 units
Illnesses reported
None reported
Manufactured in
3135 Quarry Rd, N/A, Telford, PA, United States
Classification
Class I
Recall number
Z-0934-2026

In the FDA's words

Description
Draeger Vapor 3000. Unheated, calibrated anesthetic vaporizer. A certain component of affected devices was not delivered within specification and contained impurities. Model No. M36500; UDI-DI: 04048675301363; Serial No. ASUK-1181,ASUK-1186,ASUK-1187,ASUK-1196,ASUK-1197,ASUK-1198,ASUK-1199,ASUK-1200, ASUK-1201,ASUK-1202,ASUK-1203,ASUK-1204,ASUK-1205,ASUK-1206,ASUK-1207,ASUK-1208, ASUK-1209,ASUK-1210,ASUK-1211,ASUK-1212,ASUK-1213,ASUK-1214,ASUK-1215,ASUK-1216, ASUK-1217,ASUK-1218,ASUK-1219,ASUK-1220,ASUK-1590,ASUK-1591,ASUK-1592,ASUK-1611, ASUK-1613,ASUK-1616,ASUK-1617,ASUK-1618,ASUK-1619, ASUK-0241,ASUK-0242,ASUK-0243,ASUK-0244,ASUK-0245,ASUK-0246,ASUK-0247,ASUK-0248, ASUK-0249,ASUK-0250,ASUK-0451,ASUK-0452,ASUK-0453,ASUK-0454,ASUK-0455,ASUK-0456, ASUK-0457,ASUK-0458,ASUK-0459,ASUK-0460,ASUK-0461,ASUK-0462,ASUK-0463,ASUK-0464, ASUK-0465,ASUK-0466,ASUK-0467,ASUK-0468,ASUK-0469,ASUK-0470,ASUK-0471,ASUK-0472, ASUK-0473,ASUK-0474,ASUK-0475,ASUK-0476,ASUK-0477,ASUK-0478,ASUK-0479,ASUK-0480, ASUK-0481,ASUK-0482,ASUK-0483,ASUK-0484,ASUK-0486,ASUK-0487,ASUK-0488,ASUK-0489, ASUK-0490,ASUK-0491,ASUK-0492,ASUK-0493,ASUK-0494,ASUK-0495,ASUK-0496,ASUK-0497, ASUK-0498,ASUK-0499,ASUK-0500,ASUK-0501,ASUK-0502,ASUK-0503,ASUK-0504,ASUK-0505, ASUK-0506,ASUK-0507,ASUK-0508,ASUK-0509,ASUK-0510,ASUK-0511,ASUK-0512,ASUK-0513, ASUK-0514,ASUK-0515,ASUK-0516,ASUK-0517,ASUK-0518,ASUK-0519,ASUK-0520,ASUK-0521, ASUK-0522,ASUK-0523,ASUK-0524,ASUK-0525,ASUK-0526,ASUK-0527,ASUK-0528,ASUK-0529, ASUK-0530,ASUK-0531,ASUK-0532,ASUK-0533,ASUK-0534,ASUK-0535,ASUK-0536,ASUK-0537, ASUK-0538,ASUK-0539,ASUK-0540,ASUK-0541,ASUK-0542,ASUK-0543,ASUK-0544,ASUK-0545, ASUK-0546,ASUK-0547,ASUK-0548,ASUK-0549,ASUK-0550,ASUK-0551,ASUK-0552,ASUK-0553, ASUK-0554,ASUK-0555,ASUK-0556,ASUK-0557,ASUK-0558,ASUK-0559,ASUK-0560,ASUK-1181, ASUK-1182,ASUK-1183,ASUK-1184,ASUK-1185,ASUK-1191,ASUK-1192,ASUK-1193,ASUK-1194, ASUK-1195,ASUK-1581,ASUK-1582,ASUK-1583,ASUK-1584,ASUK-1585,ASUK-1586,ASUK-1587, ASUK-1588,ASUK-1589,ASUK-1593,ASUK-1594,ASUK-1595,ASUK-1596,ASUK-1597,ASUK-1598, ASUK-1599,ASUK-1600,ASUK-1602,ASUK-1612,ASUK-1614,,ASUK-1615,ASUK-1620. Distribution: Worldwide - US Nationwide distribution in the states of AK, CA, FL, IA, KS, MD, ME, MN, NY, OH, PA, RI, SD, TN, TX, UT, W and the countries of Argentina, Australia, Belgium, Brazil, Cambodia, China, Columbia, Czech Republic, Ecuador, Egypt, France, Germany, Greece, Guatemala, Hungary, Indonesia, Israel, Japan, Kenya, Mexico, Nepal, Norway, Panama, Peru, Philippines, Poland, Romania, Saudi Arabia, Serbia, Singapore, Spain, Thailand, Turkey, United Kingdom, United Arab Emirates, Vietnam. Affected quantity: 188 units
Hazard
A certain component of affected devices was not delivered within specification and contained impurities.

2 products in this recall

The agency lists each product separately. Check every one you might have.

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