FDA-Device2022-06-29Class II

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

Bard Peripheral Vascular Inc
Hazard

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.

Sold states
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.
Affected count
1460 units
Manufactured in
1625 W 3rd St Bldg 1, Tempe, AZ, United States
Products
REF: PIG1260K, 6Fr, X10, Safe-t-Centesis Catheter drainage Kit, Sterile EO,

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1273-2022

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