PlainRecalls
FDA Devices Moderate Class II Ongoing

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

Reported: June 29, 2022 Initiated: April 22, 2022 #Z-1273-2022

Product Description

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.

Details

Units Affected
1460 units
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.
Location
Tempe, AZ

Frequently Asked Questions

What product was recalled?
REF: PIG1260K, 6Fr, X10, Safe-t-Centesis Catheter drainage Kit, Sterile EO,. Recalled by Bard Peripheral Vascular Inc. Units affected: 1460 units.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on June 29, 2022. Severity: Moderate. Recall number: Z-1273-2022.