• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 1 Device Recall BALLARD ACCESS Closed Suction System for Neonates/Pediatrics

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
 Class 1 Device Recall BALLARD ACCESS Closed Suction System for Neonates/Pediatricssee related information
Date Initiated by FirmFebruary 03, 2023
Date PostedMarch 13, 2023
Recall Status1 Terminated 3 on September 05, 2024
Recall NumberZ-1190-2023
Recall Event ID 91663
Product Classification Catheters, suction, tracheobronchial - Product Code BSY
ProductBALLARD* ACCESS Closed Suction System for Neonates/Pediatrics, Elbow Manifold.
Code Information All lots are affected. Stock Code (Lot Number): B50511 (20098277), B50611 (20098278), B50711 (20098279), B50811 (20097177, 20097177R1).
Recalling Firm/
Manufacturer
Avanos Medical, Inc.
5405 Windward Pkwy
Alpharetta GA 30004-3894
For Additional Information Contact
470-448-5591
Manufacturer Reason
for Recall
Potential for product manifold to crack during use on patients, possibly causing leaks in the respiratory circuit and can lead to the patient receiving inadequate ventilation.
FDA Determined
Cause 2
Component design/selection
ActionAvanos hand-delivered the recall notification to the single consignee on 02/03/2023. The letter instructed the customer to discontinue use of and quarantine their stock of all lots of affected units and return them. Additionally, the customer was instructed to complete and return the acknowledgement form.
Quantity in Commerce220 units
DistributionUS Nationwide distribution in the state of Oklahoma.
Total Product Life CycleTPLC Device Report

1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
-
-