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U.S. Department of Health and Human Services

Class 1 Device Recall Teleflex

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  Class 1 Device Recall Teleflex see related information
Date Initiated by Firm May 25, 2023
Date Posted June 29, 2023
Recall Status1 Open3, Classified
Recall Number Z-1829-2023
Recall Event ID 92373
510(K)Number K780900  
Product Classification Tube, tracheal (w/wo connector) - Product Code BTR
Product Slick Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal, REF 170060
Code Information UDI/DI 4026704319558, Batch numbers: 18GG31, 18HG22, 18HG32, 18HG35, 18IG09, 18IG24, 18IG27, 18JG17, 18LG12, 19AG37, 19BG12, 19CT49, 19DT15, 19DT20, 19ET22, 19ET38, 19ET77, 19FT18, 19IT14, 19IT25, 19JT42, 20DT29, 20ET04, 20FT34, 20FT54, 20GG41, KME20H1653, KME20J1236, KME20J1237, KME20L1487, KME20L2379, KME20M0494, KME21A0384, KME21A1482, KME21C0293, KME21E1411, KME21G0757, KME21G2208, KME21G2209, KME21K0548, KME21K0549, KME21L0444, KME21M1392, KME22A1512, KME22A1513, KME22B1392
Recalling Firm/
Manufacturer		 TELEFLEX LLC
3015 Carrington Mill Blvd
Morrisville NC 27560-5437
Manufacturer Reason
for Recall		 Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
FDA Determined
Cause 2		 Under Investigation by firm
Action Teleflex issued an URGENT MEDICAL DEVICE RECALL notice to its consignees on 05/25/2012 by FedEx. The notice explained the problem, the risk, and requested the following: Users should cease use and distribution of affected product and immediately quarantine the affected product. Distributors were directed to cease use, distribution, and quarantine the product, and to notify their customers. Teleflex is seeking the return of the affected product. For further information: Contact: Customer Service, Telephone: 1-866-396-2111 FAX: 1-855-419-8507, Email: Recalls@teleflex.com
Quantity in Commerce 9400 units
Distribution US Nationwide distribution including Puerto Rico.
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 = POLAMEDCO, INC.
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