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U.S. Department of Health and Human Services

Class 2 Device Recall Tube, Tracheal Bronchial

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  Class 2 Device Recall Tube, Tracheal Bronchial see related information
Date Initiated by Firm February 11, 2019
Create Date June 04, 2019
Recall Status1 Terminated 3 on November 02, 2020
Recall Number Z-1732-2019
Recall Event ID 82387
510(K)Number K030381  
Product Classification Tube, tracheostomy (w/wo connector) - Product Code BTO
Product Portex Blue Line Ultra Tracheostomy Tube Inner Cannula. One cannula comes inside a package which is labeled in part,

Product Usage:
The Portex Blue Line Ultra¿ Tracheostomy Tubes are indicated for airway maintenance of tracheostomized patients.
Code Information Item code/product number: 100/856/080 lot number: 3578884
Recalling Firm/
Manufacturer		 Smiths Medical ASD Inc.
6000 Nathan Ln N
Minneapolis MN 55442-1690
For Additional Information Contact Costumer Service
763-383-3072
Manufacturer Reason
for Recall		 Packaged with an incorrect size inner cannula.
FDA Determined
Cause 2		 Error in labeling
Action During the week of February 11, 2019, the firm sent URGENT MEDICAL DEVICE FIELD SAFETY NOTICE emails to their consignees advising them to check their stock, complete an enclosed. INSTRUCTIONS TO CUSTOMERS: 1.Locate and determine the number of affected products in your possession. (Product Number: 100/856/080 Lot Number: 3578884) 2.Complete the attached Response Form within 10 days and return it to fieldactions@smiths-medical.com, even if you do not have any of the affected product in your possession. 3.Return affected product to Stericycle utilizing the pre-paid shipping labels included with this notice. Include a copy of your completed Response Form inside EACH BOX of returned product to facilitate processing of credit. Ensure boxes are sealed and labeled with your facility name prior to shipping. 4.DISTRIBUTORS: If you have distributed potentially affected devices to your customers, please immediately notify them of this Field Safety Corrective Action. Smiths Medical is committed to providing quality products and service to its customers. We apologize for any inconvenience this situation may cause. If you have any questions regarding this notification, please contact Smiths Medical via email at fieldactions@smiths-medical.com. FIELD SAFETY NOTICE RESPONSE FORM and return an affected devices to Stericycle. The emails also instructed distributors to conduct a subrecall.
Quantity in Commerce 7,840
Distribution Worldwide Distribution - US Nationwide AL, CA, CT, FL, IL, KY, MA, MD, NC, NJ, OH, OR, PA, RI, SC, TN, UT, and VA. Canada, UK and Ireland
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 = BTO and Original Applicant = PORTEX LTD.
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