VentStar Basic (P) 180, Catalog Number MP00351 Breathing Circuits/Anesthesia Sets without a Water trap: Breathing circui

FDA device recall Z-0738-2019 · posted 2019-01-24 · Terminated

Recall details

Recalling firm

Draeger Medical, Inc.

Reason for recall

Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit of the breathing circuit

Action taken

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:denise.frey@draeger.com 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.

Root cause

Process design

Status

Terminated

Product code

OFP

Quantity affected

525 units

Distribution

US Distribution to states of: AL, CA, CO, CT, FL, KY, MI, NJ, OH, PA, SC & TX.

Date initiated

2018-12-21

Date posted

2019-01-24

Date terminated

2019-04-16

Location

Telford, PA