Device product
TRACH KIT W/HYDROGEN & SALI
Z-1044-2024
Product summary
- Event
- Event 93551
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 661,560 units
- Official record key
device-enforcement:Z-1044-2024
Official wording
Reason: Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.
Code information: REF 47802; Lot Numbers: 2201103364, 2201103464, 2201804164, 2201804264, 2204627064, 2204627364, 2204801164, 2205309664, 2205309764, 2206020664, 2206020764, 2206731664, 2206731764, 2208117464, 2208117564, 2208828064, 2208828164, 2212326364, 2213014664, 2215107664, 2215808564, 2222816264, 2216523964, 2217209464, 2219323864, 2217915264, 2219326264, 2219910964, 2221312264, 2221312164, 2222816164, 2222816364, 2223528364, 2223528464, 2224243164, 2224243264, 2224929764, 2224929864, 2225515664, 2226320664, 2225515764, 2226320764, 2227034464, 2229112364, 2227725164, 2227725264, 2227022264, 2231226564, 2231914264, 2305711364, 2305711464, 2306201964, 2300121564, 2305706564, 2306622764, 2307909364, 2307305764, 2307305664, 2307909464, 2308600464, 2310101364, 2310101464, 2311517164, 2310900364
Distribution pattern: US and EMEA, Japan, Latin America
Derived failure modes
-
Unknown
Convenience kits were manufactured and distributed with components which were subsequently recalled by Nurse Assist.