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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 Teleflexsee related information
Date Initiated by FirmMay 25, 2023
Date PostedJune 29, 2023
Recall Status1 Open3, Classified
Recall NumberZ-1898-2023
Recall Event ID 92373
510(K)NumberK993786 
Product Classification Tube, tracheal (w/wo connector) - Product Code BTR
ProductRUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Magill, REF 112480040
Code Information UDI/DI 14026704341525, Batch Numbers: 18FG14, 18FG22, 18JG08, 18KG25, 18LG04, 18LG30, 19DT35, 19DT36, 19ET09, 19ET31, 19ET51, 19HT60, 19IT32, 19IT43, 20AT06, 20AT39, 20BT01, 20BT53, 20CT12, 20CT27, 20CT54, 20DT04, 20ET30, 20FT58, KME20G0182, KME20H0372, KME20H0373, KME20J0924, KME20J2043, KME21C2368, KME21K1187, KME21K1188, KME21K1977, KME21M1084, KME21M1842, KME21M1845, KME21M2733, KME21M2734, KME21M2735, KME21M2736, KME22B2019, KME22C1693, KME22D0057, KME22D0180, KME22D0819, KME22D1066, KME22D3269, KME22E0602, KME22E2648, KME22E2681, KME22F1440, KME22F1692, KME22F2455, KME22G2312, KME22H1126, KME22H1212, KME22H2302, KME22J1615, KME22K0283, KME22K0632, KME22K1096, KME22M1155, KME22M1478, KME22M1659, KME23B3174
FEI Number 3005747797
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
ActionTeleflex 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 Commerce37076 units
DistributionUS Nationwide distribution including Puerto Rico.
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 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) Database510(K)s with Product Code = BTR
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