Device product
CADD-Legacy 1, Model 6400 Ambulatory Infusion Pump, REF 21-6400-51, PC 10008552-001, Smiths Medical ASD, Inc. Rx ONLY
Z-0307-2018
Product summary
- Event
- Event 78673
- Status
- Terminated
- Classification
- Class II
- Quantity
- 58 units
- Official record key
device-enforcement:Z-0307-2018
Official wording
Reason: Certain CADD Legacy 1, Ambulatory Infusion Pumps, may contain non-matching serial numbers. The label attached to the back of the pump may list a serial number that does not match the correct serial number programmed into the software of the pump.
Code information: Serial Numbers: 409963, 409964, 409965, 409966, 409967, 409968, 409969, 409970, 409971, 409972, 409973, 409974, 409975, 409976, 409977, 409978, 409979, 409980, 409981, 409982, 409983, 409984, 409985, 409986, 409987, 409988, 409989, 409990, 409991, 409992, 409993, 409994, 409995, 409996, 409997, 409998, 409999, 410000, 410001, 410002, 410003, 410004, 410005, 410006, 410007, 410008, 410009, 410010, 410011, 410012, 410013, 410014, 410015, 410016, 410017, 410018, 410019, 410020
Distribution pattern: US, Australia
Derived failure modes
-
Unknown
Certain CADD Legacy 1, Ambulatory Infusion Pumps, may contain non-matching serial numbers. The label attached to the back of the pump may list a serial number that does not match the correct serial number programmed into the software of the pump.