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RUSCH recallZ-1890-2023 · Teleflex LLC · initiated May 25, 2023

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Teleflex LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.

FDA root cause category: Under Investigation by firm

What the company is doing

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]

Recall details

Recall number
Z-1890-2023
Status
Open, Classified
Initiated by the company
May 25, 2023
Posted by the FDA
Jun 29, 2023
Recalling firm
Teleflex LLC
Quantity
170179 units
Product code
BTR
FDA submissions
K961837
Distribution
US Nationwide distribution including Puerto Rico.

Product description

Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff, REF 112082080

Code information (models, lots, serial numbers)

Show the full code information (2k characters)

UDI/DI 14026704341440, Batch Numbers: 18GG11, 18GG12, 18GG13, 18GT08, 18GT11, 18HG40, 18IG04, 18IG07, 18IG12, 18IG13, 18IG23, 18IT06, 18IT10, 18IT16, 18JG07, 18JG09, 18JG13, 18JG26, 18JG37, 18JG38, 18JT06, 18JT10, 19AG35, 19AG38, 19AT20, 19BG06, 19BG07, 19BG14, 19BG18, 19BG22, 19BG25, 19BG30, 19BT08, 19BT12, 19DT36, 19DT43, 19ET22, 19ET27, 19ET82, 19ET83, 19FT04, 19FT13, 19FT26, 19FT28, 19KT14, 19LT46, 19LT47, 19LT51, 20AT22, 20AT49, 20BG15, 20BG19, 20BT05, 20BT09, 20BT10, 20BT24, 20CT42, 20CT48, 20CT54, 20DT10, 20DT23, 20DT28, 20ET16, 20ET17, 20ET39, 20FT17, 20FT43, 20FT49, 20FT58, 20FT61, 20GG48, 20GT10, 20GT11, 20GT12, 20GT23, KME20G0436, KME20H0953, KME20L1706, KME20L2207, KME20L2333, KME20L2607, KME20L2696, KME20M1043, KME20M1342, KME21A1435, KME21A1524, KME21A2058, KME21B0616, KME21D1653, KME21D1946, KME21D2011, KME21D2012, KME21E0584, KME21E0687, KME21E1452, KME21F0981, KME21F1006, KME21F1215, KME21F1530, KME21F1604, KME21G0736, KME21G1100, KME21J0109, KME21J0563, KME21J1295, KME21J1364, KME21J1415, KME21J1532, KME21J2055, KME21K0022, KME21K0187, KME21K0449, KME21K2884, KME21K3013, KME21L0744, KME21L1438, KME21L1533, KME21L1661, KME21L1787, KME21L2012, KME21L2177, KME21M3032, KME21M3137, KME21M3236, KME22A0626, KME22A0793, KME22A1043, KME22A1701, KME22A2203, KME22A2429, KME22A2693, KME22A2966, KME22B0500, KME22B0737, KME22B0898, KME22B0915, KME22B0991, KME22C1987, KME22C2072, KME22C2219, KME22C2400, KME22C3376, KME22D0004, KME22D1589, KME22D1689, KME22D1897, KME22D2014, KME22D2505, KME22D2636, KME22D3062, KME22D3275, KME22D3421, KME22D3427, KME22D3712, KME22E2014, KME22F0621, KME22F2238, KME22J3346, KME22K0540, KME22K0541, KME22K0654, KME22K0691, KME22K0694, KME22K0715, KME22K0777, KME22M0921, KME23A0132, KME23A0714, KME23B1443

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

21 devices cleared under K961837 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 92373).

Sources and updates

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