Recalls / —
—#200840
Product
RUSCHELIT Safety Clear Tracheal Tube, oral/nasal, Magill, REF 112480035
- FDA product code
- BTR — Tube, Tracheal (W/Wo Connector)
- Device class
- Class 2
- Medical specialty
- Anesthesiology
- 510(k) numbers
- K780900
- Affected lot / code info
- UDI/DI 14026704341518, Batch Numbers: 18GG15, 18GG16, 18IG01, 18IG03, 18IG04, 18IG13, 18LG30, 19BG16, 19BG35, 19DT35, 19ET51, 19GT51, 19IT38, 19JT20, 19JT50, 19KT37, 19KT60, 19LT03, 19LT27, 20AT54, 20BT42, 20BT51, 20CT07, 20CT54, 20ET30, 20FT43, KME20H2894, KME20J0754, KME20J3097, KME20M2591, KME20M3049, KME20M3050, KME21A0349, KME21A3147, KME21A3239, KME21B1099, KME21C1766, KME21C2690, KME21C3242, KME21D0295, KME21D2960, KME21K1922, KME21M0820, KME21M2050, KME21M3073, KME22A0416, KME22A1499, KME22B2850, KME22C1453, KME22C1455, KME22C2694, KME22D1761, KME22D2536, KME22E0601, KME22F2453, KME22G0614, KME22G1180, KME22G1181, KME22G1876, KME22H2913, KME22H3442, KME22J2322, KME22J3348, KME22L1190, KME22L1191, KME22L1547, KME23A2353, KME23A2534, KME23B0590, KME23C0083
Why it was recalled
Reports of disconnection of the 15mm connector from the endotracheal tube (ET tube) for the affected products.
Root cause (FDA determination)
Under Investigation by firm
Action the firm took
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
Recalling firm
- Firm
- TELEFLEX LLC
- Address
- 3015 Carrington Mill Blvd, Morrisville, North Carolina 27560-5437
Distribution
- Distribution pattern
- US Nationwide distribution including Puerto Rico.
Timeline
- Recall initiated
- 2023-05-25
- Posted by FDA
- 2023-06-29
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #200840. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.