Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Oral/Nasal Tracheal Tube

  • 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 2 Device Recall Oral/Nasal Tracheal Tubesee related information
Date Initiated by FirmAugust 09, 2021
Create DateOctober 27, 2021
Recall Status1 Terminated 3 on October 13, 2023
Recall NumberZ-0178-2022
Recall Event ID 88512
510(K)NumberK792035 
Product Classification Tube, tracheal (w/wo connector) - Product Code BTR
ProductBivona Uncuffed Wire Endotracheal Tubes,
Code Information SKU 15W080 Lots #'s: 3221795, 3221796, 3226185, 3250343, 3263023, 3272646, 3301497, 3301498, 3312810, 3312811, 3315720, 3315721, 3338833, 3346070, 3361916, 3370107, 3379478, 3433337, 3437237, 3442378, 3442379, 3451013, 3459483, 3463690, 3491443, 3491444, 3491445, 3491446, 3491447, 3491448, 3507938, 3507939, 3507940, 3507941, 3512284, 3512285, 3517254, 3521999, 3531347, 3540954, 3545300, 3552748, 3565644, 3569215, 3582745, 3608114, 3608131, 3615305, 3641651, 3680769, 3700904, 3707798, 3782473, 3790044, 3890025, 3890026, 3890027, 3890028, 3890029, 3890030, 3890031, 3890032, 3890033, 3907873, 3926897, 3985080 and 3991281. SKU 15W085 SKU 15W090 SKU 15W095
FEI Number 3012307300
Recalling Firm/
Manufacturer		 Smiths Medical ASD Inc.
6000 Nathan Ln N
Minneapolis MN 55442-1690
For Additional Information ContactMr. Dave Halverson
763-383-3310
Manufacturer Reason
for Recall		Inadequate pouch seal leading to a compromised sterile barrier on products with a shaft length of 325mm.
FDA Determined
Cause 2		Process control
ActionInstructions to Consignees 1. Locate and quarantine affected product in your possession. 2. Determine the number of affected devices in your possession and complete the Response Form 3. All affected product must be returned to Sedgwick for processing. A pre-paid return shipping label will be sent to you when the Response Form is returned indicating whether impacted devices are in your possession. Instructions to Distributors DISTRIBUTORS: if you have distributed potentially affected product to your customers, please immediately notify them of this Recall and instruct them to return the Response Forms to YOU for reconciliation. Please respond for each Distribution Center affected only
Quantity in Commerce2191 devices
DistributionWorldwide distribution - US Nationwide distribution in the states of AL, AZ, CA, CT, FL, GA, IL, KY, MA, MN, MO, NE, NJ, NY, OH, PA, SD, TN, TX, VA, WA and Hawaii. The countries of Bermuda, Canada, Germany, Denmark, Great Britain and Italy.
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 = BTR
-
-