Device product
REF: PIG1260K, 6Fr, X10, Safe-t-Centesis Catheter drainage Kit, Sterile EO,
Z-1273-2022
Product summary
- Event
- Event 90201
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1460 units
- Official record key
device-enforcement:Z-1273-2022
Official wording
Reason: There is the potential that a 6 Fr Catheter Drainage kit contains an 8 Fr needle instead of a 6 Fr needle. They can be used in conjunction with the following drainage methods: Universal extension set and drainage bag, vacuum bottle, and wall suction.
Code information: Lot # 0001405396; UDI/DI: (01)10885403076114
Distribution pattern: Worldwide distribution - US Nationwide distribution in the states of MS, NC, FL, KS, GA, OH, AZ, NV, OH, IL, MI, MO,IA, CA, PA, AL,WA, TN, IN, NY and the countries of AU, BE, NZ.
Derived failure modes
-
Unknown
There is the potential that a 6 Fr Catheter Drainage kit contains an 8 Fr needle instead of a 6 Fr needle. They can be used in conjunction with the following drainage methods: Universal extension set and drainage bag, vacuum bottle, and wall suction.