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U.S. Department of Health and Human Services

Class 1 Device Recall Hudson RCI Sheridan Uncuffed

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  Class 1 Device Recall Hudson RCI Sheridan Uncuffed see related information
Date Initiated by Firm May 24, 2019
Create Date June 19, 2019
Recall Status1 Open3, Classified
Recall Number Z-1763-2019
Recall Event ID 82964
510(K)Number K822082  
Product Classification Tube, tracheal (w/wo connector) - Product Code BTR
Product Hudson RCI Sheridan:
1) Uncuffed 6.0 mm, Product Code 5-10412
2) Uncuffed 6.5 mm, Product Code 5-10413
3) Uncuffed 7.0 mm, Product Code 5-10414

Product Usage:
Tracheal tube/airway management


Code Information 1) Uncuffed 6.0 mm, Product Code 5-10412 Lot Numbers: 73J1600363 73K1600581 73L1600347 73L1600552 73L1600850 73M1600138 73A1700264 73B1700300 73C1700688 73E1700098 73E1700712 73G1700132 73H1700327 73J1700290 73K1700065 73K1700415 73L1700169 73L1700320 73M1700250 73A1800060 73B1800348 73B1800487 73C1800349 73C1800482 73D1800464 73E1800389 73F1800171 73G1800923  2) Uncuffed 6.5 mm, Product Code 5-10413 Lot Numbers: 73M1600139 73B1700301 73E1700472 73G1700127 73K1700416 73A1800061 73B1800349 73B1800488 73D1800634 73F1800544 73G1800924  3) Uncuffed 7.0 mm, Product Code 5-10414 Lot Numbers: 73A1700100 73F1700064 73L1800406   
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
Under Investigation by firm
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 14357
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = BTR and Original Applicant = SHERIDAN CATHETER CORP.
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