Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1892-2023Class I

Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082090

Teleflex Medical / initiated 2023-05-25 / Open, Classified

TELEFLEX LLC began a recall of Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082090 on . FDA classified it as Class I and gives the reason as "Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products". As of , the recall status on record is Open, Classified.

Recall record

Recall number
Z-1892-2023
Classification
Class I
Status
Open, Classified
Initiated
Posted
Recalling firm
Teleflex Medical
Product
Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082090
Product code
BTR Tube, Tracheal (W/Wo Connector)
Reason for recall
Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
FDA root cause
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: [email protected]
Quantity in commerce
30423 units
Distribution
US Nationwide distribution including Puerto Rico.
Product codes and lots
UDI/DI 14026704341464, Batch Numbers: 18FG23, 18FT17, 18FT24, 18FT25, 18FT49, 18GG12, 18GG26, 18JG38, 18KG04, 18KG05, 18KG23, 18KG26, 18KG38, 18KT04, 18KT27, 18LG13, 19AT19, 19CG02, 19ET11, 19JT61, 19KT35, 19LT35, 19LT46, 20AT57, 20BT38, 20DT28, KME20H0415, KME20H2140, KME20H2314, KME20H2913, KME20J1999, KME20K0212, KME20K0600, KME20K1434, KME20K3525, KME20L0805, KME21K0478, KME21L1274, KME21L1371, KME22A2199, KME22A2286, KME22A2317, KME22B1140, KME22B1997, KME22B2180, KME22C0133, KME22C0202, KME22C0454, KME22C0573, KME22C0675, KME22D3492, KME22E1281, KME22E1282, KME22E2749, KME22F2444, KME22H2380, KME22K0996, KME23A2734, KME23B2546

Enforcement reports

One row per recalled product line
FDA enforcement reports joined to recall event Z-1892-2023
Recall numberClassStatusVoluntary or mandatedReport dateClassified
Z-1827-2023Class IOngoingVoluntary: Firm initiated
Z-1828-2023Class IOngoingVoluntary: Firm initiated
Z-1829-2023Class IOngoingVoluntary: Firm initiated
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Z-1890-2023Class IOngoingVoluntary: Firm initiated
Z-1891-2023Class IOngoingVoluntary: Firm initiated
Z-1892-2023Class IOngoingVoluntary: Firm initiated
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