Z-1178-2021Class II

VentStar Basic (N) 180- Drager Breathing Circuits/Anesthesia Sets Order Number: MP00353 -

Name: Z-1178-2021 VentStar Basic (N) 180- Drager Breathing Circuits/Anesthesia Sets Order Number: MP00353 -
Creator: Draeger Medical, Inc.
Published: 2021-01-29
License: https://open.fda.gov/license/

Draeger, Inc. / initiated 2021-01-29 / Terminated / root cause: manufacturing process

FDA source

Draeger Medical, Inc. began a recall of VentStar Basic (N) 180- Drager Breathing Circuits/Anesthesia Sets Order Number: MP00353 - Product Usage: Breathing circuit for conduction of respiratory gases... on 2021-01-29. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1178-2021
Classification: Class II
Status: Terminated
Initiated: 2021-01-29
Posted: 2021-03-05
Terminated: 2021-11-01
Recalling firm: Draeger, Inc.
Product: VentStar Basic (N) 180- Drager Breathing Circuits/Anesthesia Sets Order Number: MP00353 - Product Usage: Breathing circuit for conduction of respiratory gases between anesthesia machine or ventilator and patient. Intended for single use only.
Product code: OFP Anesthesia Breathing Circuit Kit (Adult & Pediatric)
Reason for recall: 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 tag: manufacturing process
FDA 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 in commerce: 1,525 units
Distribution: US Nationwide distribution.
Product codes and lots: All lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1178-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1177-2021	Class II	Terminated	Voluntary: Firm initiated	2021-03-17	2021-03-05
Z-1178-2021	Class II	Terminated	Voluntary: Firm initiated	2021-03-17	2021-03-05
Z-1179-2021	Class II	Terminated	Voluntary: Firm initiated	2021-03-17	2021-03-05
Z-1180-2021	Class II	Terminated	Voluntary: Firm initiated	2021-03-17	2021-03-05

Product code OFP

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)