Recall Z-0736-2019 ยท OFP Anesthesia Breathing Circuit Kit (Adult & Pediatric)
Draeger Medical, Inc.
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 pe
| Date | Jan 24, 2019 (initiated Dec 21, 2018) |
| Status | Terminated |
| Reason | Incorrectly pre-assembled breathing circuit has potential for incorrect connection/short circuit of the breathing circuit |
| 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 b |
| Quantity | 325 units |
| Distribution | US Distribution to states of: AL, CA, CO, CT, FL, KY, MI, NJ, OH, PA, SC & TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.