Device product
H4002S Neonatal/Paed.Intubation Kit 3.0mm Murphy, 15mm Conn, Holder Pediatric Endotracheal Intubation Kit
Z-2539-2014
Product summary
- Event
- Event 68739
- Status
- Terminated
- Classification
- Class I
- Quantity
- 135,518 (110,246 nationwide)
- Official record key
device-enforcement:Z-2539-2014
Official wording
Reason: The tube fastener on the ET Tube Holder may compress the tracheal tube when used which may cause difficulty when locking the ET Tube Holder in place or difficulty when passing a suction catheter.
Code information: Lot Numbers: 2481849, 2474643, 2470640, 2470639, 2465819, 2462292, 2462291, 2457748, 2453455, 2448671, 2443372, 2438612, 2428206, 2420088, 2412135, 2394046, 2394045, 2394044, 2385648, 2380341, 2376618, 2376489, 2365439, 2361588, 2343298, 2329576, 2326894, 2322814, 2317088, 2309465, 2309464, 2298739, 2298738, 2286586, 2278062, 2271339, 2188449, 2179222, 2164289, 2146292, 2142175, 2137959, 2128629, 2119945, 2109011, 2099501, 2090215, 2068121, 2063971, 2063970, 2042408, 12046, 11871, 11862, 11858, 11696, 11693, 11656, 11653
Distribution pattern: Worldwide Distribution - USA including AK, AR, AZ, CA, CO, CT, DC, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, WV and Internationally to CA, CY, GB, IE, IT, JE, KW, MT, PL, RU, SA, ZA.
Derived failure modes
-
Unknown
The tube fastener on the ET Tube Holder may compress the tracheal tube when used which may cause difficulty when locking the ET Tube Holder in place or difficulty when passing a suction catheter.