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Product Description
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Recall Class
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FDA Recall Posting Date
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Recalling Firm
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Z-1824-2022 - Amplatz extra Stiff Wire Guide, Stiff Guidewire (OUS ONLY);
Reference Part Number:
THSF-35-145-AES-SGH (GPN G06801)
THSF-38-80-AES-SGH (GPN G06874)
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2
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09/28/2022
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Cook Incorporated
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Z-1847-2022 - Movable Core Wire Guide (Tefcor), Guidewire (OUS ONLY)
Reference Part Number/GPN
TMT-35-145 G01677
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2
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09/28/2022
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Cook Incorporated
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Z-1826-2022 - Bentson Wire Guide, Guidewire (OUS ONLY);
Reference Part Number:
TSMB-35-145 (GPN G27041)
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2
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09/28/2022
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Cook Incorporated
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Z-1827-2022 - Bentson Wire Guide (20cm Distal Flexibility with Softened Tip), Guidewire;
Reference Part Number:
TSFB-35-80 (GPN G01315)
TSFB-35-145 (GPN G00691)
TSFB-35-200 (GPN G01095)
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2
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09/28/2022
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Cook Incorporated
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Z-1828-2022 - Coons Interventional Wire Guide, Guidewire;
Reference Part Number/GPN:
THSF-35-145-COONS G02356
THSF-38-145-COONS G02324
THSF-35-180-COONS G02621
THSF-35-80-COONS G12268
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2
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09/28/2022
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Cook Incorporated
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Z-1829-2022 - Cope Mandril Wire Guide (Nitinol), Nitinol Guidewire;
Reference Part Number/GPN:
PMG-18SP-60-COPE-NT-ST G09395
PMG-18SP-100-COPE-NT G08687
PMG-18SP-60-COPE-NT G08427
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2
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09/28/2022
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Cook Incorporated
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Z-1830-2022 - Cope Mandril Wire Guide (Stainless Steel), Stainless Steel Guidewire
Reference Part Number/GPN
PMG-18SP-60-COPE G05183
PMG-18SP-100-COPE G05822
PMG-18SP-125-COPE G10077
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2
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09/28/2022
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Cook Incorporated
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Z-1831-2022 - Double Flexible Tipped Wire Guide, Guidewire
Reference Part Number/GPN
TDOC-35-145-0-3 G00362
C-TDOC-18-50-0-2 G05146
TDOC-35-50-0-3 G00364
C-DOC-21-40-0-2 G02431
C-TDOC-21-50-0-2 G05195
C-TDOC...
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2
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09/28/2022
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Cook Incorporated
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Z-1832-2022 - Fixed Core Wire Guide, Guidewire
Reference Part Number/GPN
THSCF-25-180-3 G02165
TSCF-25-80-3 G00476
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2
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09/28/2022
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Cook Incorporated
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Z-1833-2022 - 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-...
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2
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09/28/2022
|
Cook Incorporated
|