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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-0164-2022 - REF/Catalogue Number GSX0030A, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132631032
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2
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10/22/2021
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W L Gore & Associates, Inc.
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Z-0165-2022 - REF/Catalogue Number GSX0020A, GORE CARDIOFORM SEPTAL OCCLUDER 20 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132631018
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2
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10/22/2021
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W L Gore & Associates, Inc.
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Z-0166-2022 - REF/Catalogue Number GSX0025A, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132631025
*Not distributed within t...
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2
|
10/22/2021
|
W L Gore & Associates, Inc.
|
Z-0167-2022 - REF/Catalogue Number GSXE0020, GORE CARDIOFORM SEPTAL OCCLUDER 20 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132617630
*Not distributed within t...
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2
|
10/22/2021
|
W L Gore & Associates, Inc.
|
Z-0172-2022 - REF/Catalogue Number GSX0030H, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132648948
*Not distributed within t...
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2
|
10/22/2021
|
W L Gore & Associates, Inc.
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Z-0169-2022 - REF/Catalogue Number GSXE0030, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132617661
*Not distributed within t...
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2
|
10/22/2021
|
W L Gore & Associates, Inc.
|
Z-0170-2022 - REF/Catalogue Number GSXE0025B, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132620111
*Not distributed within ...
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2
|
10/22/2021
|
W L Gore & Associates, Inc.
|
Z-0171-2022 - REF/Catalogue Number GSXE0030B, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132620128
*Not distributed within ...
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2
|
10/22/2021
|
W L Gore & Associates, Inc.
|
Z-0168-2022 - REF/Catalogue Number GSXE0025, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132617647
*Not distributed within t...
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2
|
10/22/2021
|
W L Gore & Associates, Inc.
|