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U.S. Department of Health and Human Services

Class 2 Device Recall UniPerc(R) Adjustable Flange Tracheostomy Tube kit

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  Class 2 Device Recall UniPerc(R) Adjustable Flange Tracheostomy Tube kit see related information
Date Initiated by Firm August 14, 2017
Create Date September 26, 2017
Recall Status1 Terminated 3 on June 18, 2019
Recall Number Z-3213-2017
Recall Event ID 77957
510(K)Number K962175  
Product Classification Tube tracheostomy and tube cuff - Product Code JOH
Product UniPerc(R) Adjustable Flange Tracheostomy Tube kit, Reorder Number 100/897/080 CZ


The UniPerc(R) Tracheostomy Tubes can be used during the surgical placement of a stoma or as a replacement tube to an already existing stoma for patients with larger necks. The tracheostomy tubes are removed and may be replaced after no more than 30 days with an identical device. The range may include the following configurations: cuffed or uncuffed tracheostomy tubes, tracheostomy tube inner cannula, cleaning brushes and tracheostomy tube holder.
Code Information Lot number 3308971
Recalling Firm/
Manufacturer		 Smiths Medical ASD Inc.
6000 Nathan Ln N
Minneapolis MN 55442-1690
Manufacturer Reason
for Recall		 Smiths Medical became aware that one lot of the 8.0mm UniPerc(R) Adjustable Flange Tracheostomy Tube kit, product reorder number 100/897/080 CZ, lot number 3308971, contains an incorrect 9.0mm sized obturator instead of the correct 8.0mm sized obturator.
FDA Determined
Cause 2		 Under Investigation by firm
Action Smiths Medical sent an Urgent Medical Device Recall letter dated August 7, 2017. The consignees were directed to identify the recalled product, return it to Stericycle, and respond to the recalling firm within 10 days of receipt. For further questions, please call (763) 383-3000.
Quantity in Commerce 89 units
Distribution INTERNATIONAL ONLY: GB, FR, AT, DE, IT, SE, IE, BE, ES, LU
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = JOH and Original Applicant = SMITHS INDUSTRIES MEDICAL SYSTEMS, INC.
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