FDA Medical Device Recalls (openFDA)
Draeger Medical, Inc.: ID Circuit Basic (N) 180-Drager Breathing Circuits/Anesthesia Sets Order Number: MP01327 - Product Usage: Breathing circuit for conduction of respiratory gases between anesthesia machine or ventilator and patient. Intended for single use only.
- Recall number
- Z-1180-2021
- Recalling firm
- Draeger Medical, Inc.
- Product
- ID Circuit Basic (N) 180-Drager Breathing Circuits/Anesthesia Sets Order Number: MP01327 - Product Usage: Breathing circuit for conduction of respiratory gases between anesthesia machine or ventilator and patient. Intended for single use only.
- Status
- Terminated
- Initiated
- 2021-01-29
- Posted
- not on file
- Terminated
- 2021-11-01
- Reason
- Y-piece may become detached from the ventilation hose either before or during the ventilation process, a leak will be caused that can hinder ventilation of the patient.
- Root cause
- Process control
- Action
- Draeger Inc. (US) issued Urgent Medical Device Recall Letter via Certified Mail on January 29, 2021. The letter states reason for recall, health risk and action to take: Please check the quality of the adhesive joint before use by holding the Y-piece with one hand and then pulling (not twisting) each of the two hoses one after another so that the hose just starts to stretch visibly. Hoses that you have tested in this manner may be used if they pass the leakage test before use. Only use the hoses with devices that we have declared compatible in the Instructions for Use or accessories list of the basic device. Ensure that the patient is adequately monitored and select suitable alarm limits. During installation and operation, make sure to avoid any unnecessary tensile forces, and do not use the hoses for longer than is specified in the Instructions for Use. Please inspect your existing stock before use by following the above inspection instructions. Please also complete and return the attached Customer Reply and Order form to confirm to us that you have received this information. If you wish, we will be happy to replace any of your unused stocks that were manufactured between 01.01.2018 and 13.11.2020. The form may also be used to order Free of Charge replacements. Questions regarding this letter, please contact Michael Kelhart between the hours of 8:00 AM 4:30 PM EST at 1-800-437-2437 (press 1 at the prompt, then 32349).
- Quantity
- 25 units
- Distribution
- US Nationwide distribution.
- Lot, serial or model codes
- All lots
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- OFP
- Firm FEI
- 2517967
- Firm city
- Telford
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
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Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28