Datex-Ohmeda Auxiliary Common Gas Outlet Conversion Kits Recalled
Datex-Ohmeda is recalling 649 Auxiliary Common Gas Outlet (ACGO) conversion kits due to a potential issue if a patient breathing circuit limb is mistakenly connected to the ACGO port.
What this means for you
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 involves a medical device with a potential risk of harm due to incorrect connection of patient breathing circuits, but no injuries or illnesses have been reported, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Datex-Ohmeda, Inc. is recalling 649 units of Auxiliary Common Gas Outlet (ACGO) conversion and installation kits. These kits are sold under the product names CONV KIT SCGO TO ACGO and ACGO ASSY FIELD INSTL. The recall includes these kits because they are purchased with or later used to convert to the ACGO system, even though the kits themselves are not specifically affected by the defect.
The recall is issued due to a potential issue that may arise if the limb of a patient breathing circuit is mistakenly connected to the Auxiliary Common Gas Outlet (ACGO) port. The affected devices are not model or lot specific; all devices of the indicated products configured with the ACGO option are potentially affected. The spare part numbers for these kits are 1009-8249-000 and 1011-8071-000.
The products were distributed worldwide, including the United States and numerous international locations. No specific illnesses or injuries are reported in the source text. Healthcare facilities and users should verify if they possess these specific conversion kits and follow the instructions provided by Datex-Ohmeda, Inc. for the recall.
The recalled product
- Product
- Auxiliary Common Gas Outlet (ACGO) conversion/install kits sold under product names CONV KIT SCGO TO ACGO and ACGO ASSY FIELD INSTL. These kits are not affected specifically, however are included due to being purchased with or later used to convert to ACGO.
- Manufacturer
- Datex-Ohmeda, Inc.
- Affected units
- 649
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 (1)
- No GTIN. Spare Part Numbers: 1009-8249-000
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 11 recalled by Datex-Ohmeda, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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