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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-1210-04 - Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded iliac leg graft - distal cuff diameter 24 mm - usable length 71mm - delivery system 16 FR; Catalog no. TFLE-2...
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2
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07/27/2004
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Cook, Inc.
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Z-1211-04 - Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded iliac leg graft - distal cuff diameter 24 mm - usable length 88mm - delivery system 16 FR; Catalog no. TFLE-2...
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2
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07/27/2004
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Cook, Inc.
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Z-1212-04 - Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded iliac leg graft - distal cuff diameter 8 mm - usable length 105mm - delivery system 14 FR; Catalog no. TFLE-8...
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2
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07/27/2004
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Cook, Inc.
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Z-1213-04 - Cook brand Zenith AAA Iliac leg graft with the H&L-B One-Shot Introducer System, preloaded iliac leg graft - distal cuff diameter 8 mm - usable length 88mm - delivery system 14 FR; Catalog no. TFLE-8-...
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2
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07/27/2004
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Cook, Inc.
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Z-1214-04 - Cook brand Keller-Timmermans Introducer Set, straight with Rutner adapter includes: sheath 18.0 FR, 65 cm long without wire guide; Catalog no. VSSW-18.0-38-65-0-KTI.
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2
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07/27/2004
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Cook, Inc.
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Z-1215-04 - Cook brand Keller-Timmermans Introducer Set, curved with Rutner adapter includes: sheath 18.0 FR, 85 cm long without wire guide; Catalog no. VSSW-18.0-38-65-0-KTI-BNS.
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2
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07/27/2004
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Cook, Inc.
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Z-1216-04 - Cook brand Keller-Timmermans Introducer Set, straight with Rutner adapter includes: sheath 18.0 FR, 85 cm long without wire guide; VSSW-18.0-38-85-0-KTI.
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2
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07/27/2004
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Cook, Inc.
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Z-1217-04 - Cook brand Keller-Timmermans Introducer Set, curved with Rutner adapter includes: sheath 18.0 FR, 85 cm long without wire guide; VSSW-18.0-38-85-C-KTI.
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2
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07/27/2004
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Cook, Inc.
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Z-1218-04 - Cook brand Zenith rupture main body graft, preloaded graft measuring 22 mm diameter at promial end and 12 mm diameter at distal end, with the H&L-B One Shot Introducer System, non-sterile, export only...
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2
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07/27/2004
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Cook, Inc.
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Z-1161-04 - Cook brand Zenith AAA Endovascular Graft Iliac Leg Extensions - diameter 14 mm - length 55 mm -introducer sheath size 14 FR; Reorder no. ESLE-14-55-TAG.
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2
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07/27/2004
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Cook, Inc.
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