FDA recall Z-1825-2022

Product

Bentson Plus Wire Guide (Extra Body/20cm Distal Flexibility with Softened Tip), Guidewire; Reference Part Number: TSFBP-35-180 (GPN G09782) TSFBP-35-145 (GPN G09735)

Reason for recall

Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.

Distribution

Domestic distribution nationwide. Foreign distribution worldwide.

Key facts

Status

Ongoing

Initiation date

2022-08-16

Report date

2022-10-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

Bloomington, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1825-2022