Z-1895-2023Class I
RUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Magill, REF 112480025
Teleflex Medical / initiated 2023-05-25 / Open, Classified
TELEFLEX LLC began a recall of RUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Magill, REF 112480025 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-1895-2023
- Classification
- Class I
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Teleflex Medical
- Product
- RUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Magill, REF 112480025
- 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
- 66244 units
- Distribution
- US Nationwide distribution including Puerto Rico.
- Product codes and lots
- UDI/DI 14026704341495, Batch Numbers: 18FG31, 18GT32, 18IG03, 18IG29, 18KG08, 18LG03, 19AG08, 19AG38, 19BG12, 19BG35, 19DT13, 19DT36, 19ET51, 19FT12, 19FT28, 19GT02, 19HT05, 19HT79, 19IT59, 19LT08, 19LT31, 20BG15, 20BT01, 20CT07, 20DT24, 20ET53, 20GT38, KME20H2416, KME20H2417, KME20J1068, KME20K2143, KME20K2598, KME20L0449, KME20L1346, KME20M0127, KME20M1797, KME21A0348, KME21B0087, KME21B0465, KME21C0163, KME21C1805, KME21C2447, KME21C2688, KME21C3244, KME21K2877, KME22A1408, KME22A2390, KME22A2545, KME22B0845, KME22B2017, KME22B2848, KME22C2802, KME22E0598, KME22E2130, KME22E2191, KME22G1878, KME22G2593, KME22H0532, KME22H1185, KME22H2178, KME22H2180, KME22J1309, KME22J2321
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1827-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1828-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1829-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1830-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1831-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1832-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1833-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1834-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1835-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1836-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1837-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1838-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1839-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1840-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1841-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1842-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1843-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1844-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1845-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1846-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1847-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1848-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1849-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1850-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1851-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1852-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1853-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1854-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1855-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1856-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1857-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1858-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1859-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1860-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1861-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1862-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1863-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1864-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1865-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1866-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1867-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1868-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1869-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1870-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1871-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1872-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1873-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1874-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1875-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1876-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1877-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1878-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1879-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1880-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1881-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1882-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1883-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1884-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1885-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1886-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1887-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1888-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1889-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1890-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1891-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1892-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1893-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1894-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1895-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1896-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1897-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1898-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1899-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1900-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1901-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1902-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1903-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1904-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1905-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1922-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1923-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1924-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1925-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1926-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1927-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1928-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1929-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1930-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1931-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1932-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1933-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1934-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1935-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1936-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1937-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1938-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1939-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1940-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1941-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1942-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1943-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1944-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1945-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1946-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1947-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1948-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1949-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1950-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1951-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1952-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1953-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1954-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1955-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1956-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1957-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1958-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1959-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1960-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1961-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1962-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1963-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1964-2023 | Class I | Ongoing | Voluntary: Firm initiated | ||
| Z-1965-2023 | Class I | Ongoing | Voluntary: Firm initiated |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.