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Recall Observatory FDA recall evidence

Device product

REF: PIG1260K, 6Fr, X10, Safe-t-Centesis Catheter drainage Kit, Sterile EO,

Z-1273-2022

April 22, 2022

Class II

Product summary

Firm
Bard Peripheral Vascular Inc
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

    reason.no_named_rule · v1.0.0

    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.