Z-0736-2019Class I

VentStar Basic 180, Catalog Number MP00349 Breathing Circuits/Anesthesia Sets without a Water trap: Breathing...

Name: Z-0736-2019 VentStar Basic 180, Catalog Number MP00349 Breathing Circuits/Anesthesia Sets without a Water trap: Breathing...
Creator: Draeger Medical, Inc.
Published: 2018-12-21
License: https://open.fda.gov/license/

Draeger, Inc. / initiated 2018-12-21 / Terminated / root cause: manufacturing process

FDA source

Draeger Medical, Inc. began a recall of VentStar Basic 180, Catalog Number MP00349 Breathing Circuits/Anesthesia Sets without a Water trap: Breathing circuit for conduction of respiratory gases... on 2018-12-21. FDA classified it as Class I and gives the reason as "Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit of the breathing circuit". 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-0736-2019
Classification: Class I
Status: Terminated
Initiated: 2018-12-21
Posted: 2019-01-24
Terminated: 2019-04-16
Recalling firm: Draeger, Inc.
Product: VentStar Basic 180, Catalog Number MP00349 Breathing Circuits/Anesthesia Sets without a Water trap: Breathing circuit for conduction of respiratory gases between anesthesia machine or ventilator and patient. Intended for single use only. Breathing Circuits/Anesthesia Sets with Water trap: Breathing circuit for conveying breathing gases between an anesthesia delivery system or ventilator and a pediatric patient. Intended for single use only. Water traps are intended for collection of condensate. The standard breathing circuit is equipped with a water trap in each breathing hose limb.
Product code: OFP Anesthesia Breathing Circuit Kit (Adult & Pediatric)
Reason for recall: Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit of the breathing circuit
Root cause tag: manufacturing process
FDA root cause: Process design
Action: On Friday 12/21/2018, Draeger, Inc. issued an "Urgent Medical Device Recall Notification" and Customer Reply and Order Form to consignees via Certified Mail. Two Recall Notifications/Customer Reply and Order forms will be sent to each facility. One will be addressed to Risk Manager. The other will be addressed to Purchasing/Materials Manager. Based on customer response, Draeger will replace any affected Breathing Circuits/Anesthesia Sets Free of Charge. Customers are advised to take the following action: - Before each use, and also after any temporary disconnection, please check whether the breathing circuit is assembled such that both the inspiratory and the expiratory connector of the ventilator or anesthesia machine are each connected to the y-piece. - Please inspect your existing stock by following the inspection instructions in the attachment and complete and return the attached Customer Reply and Order form via fax to:215-372-2940 or email to:[email protected] to confirm to us that you have carried out the inspections. The form is also used to order Free of Charge replacements if you find any breathing circuits that have been incorrectly pre-assembled. - The correct set-up of the breathing circuit is illustrated in the Instructions for Use not only of the hose systems but also of the anesthesia machines and ventilators. Connection to the device must be checked prior to use. An incorrectly pre-assembled breathing circuit can be detected because it will not be a single cohesive hose system but two separate sub-systems. Customers with questions, please call 1-800-437-2437 (press 1 at the prompt, then 32349).between the hours of 8:00 AM 4:30 PM EST.
Quantity in commerce: 325 units
Distribution: US Distribution to states of: AL, CA, CO, CT, FL, KY, MI, NJ, OH, PA, SC & TX.
Product codes and lots: All lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0736-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0736-2019	Class I	Terminated	Voluntary: Firm initiated	2019-01-30	2019-01-24
Z-0737-2019	Class I	Terminated	Voluntary: Firm initiated	2019-01-30	2019-01-24
Z-0738-2019	Class I	Terminated	Voluntary: Firm initiated	2019-01-30	2019-01-24
Z-0739-2019	Class I	Terminated	Voluntary: Firm initiated	2019-01-30	2019-01-24
Z-0740-2019	Class I	Terminated	Voluntary: Firm initiated	2019-01-30	2019-01-24
Z-0741-2019	Class I	Terminated	Voluntary: Firm initiated	2019-01-30	2019-01-24
Z-0742-2019	Class I	Terminated	Voluntary: Firm initiated	2019-01-30	2019-01-24
Z-0743-2019	Class I	Terminated	Voluntary: Firm initiated	2019-01-30	2019-01-24
Z-0744-2019	Class I	Terminated	Voluntary: Firm initiated	2019-01-30	2019-01-24

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)