FDA recall Z-1273-2022

Product

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

Reason for recall

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.

Distribution

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.

Key facts

Status

Ongoing

Initiation date

2022-04-22

Report date

2022-06-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Tempe, AZ, United States

Primary source

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