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Cook Incorporated Recall: Fixed Core Wire Guide (Safe-T-J Curved), Guidewire Reference Par

Cook Incorporated Recall: Fixed Core Wire Guide (Safe-T-J Curved), Guidewire Reference Par is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Cook Incorporated; Product: Fixed Core Wire Guide (Safe-T-J Curved), Guidewire Reference Part Number/GPN: TSCF-25-180-3 G01602 TSCF-35-180-3 G00902

Recalling firmCook Incorporated
ProductFixed 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 recallCook 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.
ClassificationClass II (moderate — may cause temporary or reversible health consequences)
StatusOngoing
DistributionDomestic distribution nationwide. Foreign distribution worldwide.
Recall initiated20220816
Recall numberZ-1833-2022
Categorydevice
StateIN
CountryUnited States

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