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U.S. Department of Health and Human Services

Class 1 Device Recall Sheridan/HVT Novaplus

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  Class 1 Device Recall Sheridan/HVT Novaplus see related information
Date Initiated by Firm May 24, 2019
Date Posted June 19, 2019
Recall Status1 Terminated 3 on February 15, 2022
Recall Number Z-1766-2019
Recall Event ID 82964
510(K)Number K822082  
Product Classification Tube, tracheal (w/wo connector) - Product Code BTR
Product Sheridan/HVT:
1) Novaplus 7.0 mm, Product Code V5-10314
2) Novaplus 7.5 mm, Product Code V5-10315
3) Novaplus 8.0 mm, Product Code V5-10316
4) Novaplus 8.5 mm, Product Code V5-10317

Product Usage:
Tracheal tube/airway management
Code Information 1) Novaplus 7.0 mm, Product Code V5-10314 Lot Numbers: 73J1600387 73J1600388 73K1600157 73K1600603 73K1600604 73K1600736 73L1600367 73L1600368 73L1600502 73L1600870 73M1600165 73M1600270 73A1700121 73A1700122 73B1700322 73B1700428 73C1700426 73C1700576 73C1700577 73C1700702 73C1700703 73E1700106 73E1700107 73E1700108 73E1700239 73F1700560 73G1700147 73G1700148 73G1700302 73G1700303 73G1700623 73G1700624 73H1700055 73H1700497 73H1700568 73H1700628 73J1700309 73K1700086 73K1700087 73K1700616 73A1800296 73A1800430 73B1800218 73B1800372 73B1800373 73B1800374 73B1800512 73B1800513 73C1800373 73C1800574 73C1800575 73D1800656 73D1800657 73E1800580 73E1800581 73E1800809 73F1800723 73G1800107 73H1800205 73H1800456 73H1800457 73H1800759 73H1800760 73J1800120 73J1800534 73J1800697  2) Novaplus 7.5 mm, Product Code V5-10315 Lot Numbers: 73J1600389 73J1600580 73J1600581 73K1600158 73L1600260 73L1600518 73L1600672 73M1600268 73A1700289 73A1700290 73A1700741 73B1700165 73B1700638 73C1700265 73D1700137 73D1700138 73D1700266 73D1700267 73E1700240 73F1700281 73F1700365 73F1700414 73G1700237 73G1700437 73H1700056 73H1700352 73H1700629 73H1700796 73J1700443 73K1700435 73K1700436 73K1700754 73L1700672 73L1700673 73A1800687 73A1800795 73B1800514 73D1800158 73D1800286 73E1800098 73E1800309 73E1800312 73E1800407 73E1800408 73F1800191 73F1800192 73F1800362 73F1800363 73G1800595 73G1800831 73H1800078 73H1800688 73H1800761 73J1800327 73K1800322  3) Novaplus 8.0 mm, Product Code V5-10316 Lot Numbers: 73J1600582 73J1600772 73K1600605 73L1600174 73L1600369 73L1600370 73L1600673 73L1600871 73A1700428 73A1700661 73B1700625 73D1700430 73D1700431 73D1700432 73D1700631 73F1700038 73F1700039 73F1700734 73G1700438 73G1700625 73H1700353 73H1700499 73H1700797 73J1700144 73J1700493 73J1700610 73K1700617 73M1700150 73A1800070 73B1800728 73B1800729 73C1800205 73C1800207 73D1800291 73D1800483 73D1800484 73E1800810 73G1800234 73G1800596 73H1800458 73J1800334 73J1800698 73K1800195  4) Novaplus 8.5 mm, Product Code V5-10317 Lot Numbers: 73L1600674 73B1700639 73C1700704 73D1700632 73F1700561 73G1700439 73H1700354 73M1700025 73B1800730 73F1800193 73G1800019 73H1800093 73K1800574   
Recalling Firm/
Manufacturer		 Teleflex Medical
3015 Carrington Mill Blvd
Morrisville NC 27560-5437
Manufacturer Reason
for Recall		 This voluntary recall is due to reported complaints (<0.0025% of all in scope distributed product) indicating that there is an increased incidence of specific lots of the 15 mm Sheridan connector becoming disconnected from the Endotracheal tube.
FDA Determined
Cause 2		 Process control
Action Teleflex sent an Urgent Medical Device Recall letter dated May 24, 2019 to customers. The letter identified the affected product, problem and actions to be taken. The letter directed customers to discontinue use, quarantine the product, and contact Teleflex for return of the product. Distributors were directed to notify their customers and request the customer return the recalled products to them for consolidation and subsequent return to Teleflex.. For questions contact your local sales representative or Customer Service at 1-866-396-2111
Quantity in Commerce 1390944 units
Distribution Worldwide - US Nationwide Distribution
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 = BTR and Original Applicant = SHERIDAN CATHETER CORP.
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