FDA recall Z-1833-2022

Product

Fixed Core Wire Guide (Safe-T-J Curved), Guidewire Reference Part Number/GPN: TSCF-25-180-3 G01602 TSCF-35-180-3 G00902 TSCF-21-260-3 G00455 THSCF-25-260-3 G02384 TSCF-25-145-3 G00466 THSCF-35-80-3 G04069 THSCF-35-180-15 G01151 TSCF-21-50-3 G00456 THSCF-35-145-3 G00412 TSCF-35-145-15 G00509 TSCF-35-145-1.5 G00507 TSCF-35-145-3 G00511 TSCF-38-80-3 G00552 TSCF-18-180-3 G02160 TSCF-35-80-3 G00529 TSCF-21-180-3 G01793 TSCF-25-260-3 G00471 C-SCF-18-50-3 G02050 C-SCF-18-40-2 G02659 C-SCF-25-50-3 G02180 TSCF-18-80-3 G00441 C-SCF-15-30-2 G06973

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-1833-2022