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U.S. Department of Health and Human Services

Class 2 Device Recall Bivona Tracheostomy Tubes

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 Class 2 Device Recall Bivona Tracheostomy Tubessee related information
Date Initiated by FirmAugust 28, 2020
Create DateSeptember 09, 2020
Recall Status1 Terminated 3 on May 13, 2021
Recall NumberZ-2946-2020
Recall Event ID 86345
510(K)NumberK083641 K914088 
Product Classification Tube tracheostomy and tube cuff - Product Code JOH
ProductBivona Mid-Range Aire-Cuf Adult Tracheostomy Tube This tube is intended to provide direct airway access for a tracheotomized patient for up to 29 days. It may be reprocessed up to 10 times for single patient use.
Code Information Lot# 3952216
Recalling Firm/
Manufacturer		 Smiths Medical ASD Inc.
6000 Nathan Ln N
Minneapolis MN 55442-1690
For Additional Information ContactDave Halverson
763-383-3072
Manufacturer Reason
for Recall		Label has the incorrect size for the tracheotomy tube.
FDA Determined
Cause 2		Error in labeling
ActionOn 08/28/20, the firm, Smiths Medical, sent an "URGENT MEDICAL DEVICE RECALL NOTICE" to its consignees. The consignee was instructed to follow: INSTRUCTIONS TO CUSTOMERS: 1. Locate and quarantine the affected Bivona Mid-Range Aire-Cuf Tracheostomy Tubes in your possession by referring to the attached Urgent Medical Device Recall Response Form. This form identifies the one (1) specific lot number and quantity distributed to your facility. ONLY UNUSED PRODUCT SHOULD BE QUARANTINED FOR RETURN. 2. Complete the attached Urgent Medical Device Recall Form within 10 days of receipt and return it to fieldactions@smiths-medical.com. The form must be returned even if you do not have any affected product in your possession. Product credit will be processed once the Urgent Medical Device Field Recall Response Form is received. 3. All affected product must be returned to Compliance at Smiths Medical for processing. Pre-paid shipping labels will be sent once you have returned the completed response form attached with this notice. Include a copy of your completed Response Form inside the package of returned product to facilitate processing. Make sure packages are sealed and labeled with your facility name prior to shipping to Smiths Medical. If you have any questions regarding this notification, please contact Smiths Medical via email at fieldactions@smiths-medical.com.
Quantity in Commerce3 units
DistributionUS Distribution to state of: CT
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.
510(K) Database510(K)s with Product Code = JOH
510(K)s with Product Code = JOH
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