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Manufacturers
C.R. Bard Access Systems, Inc
Manufacturer Address
C.R. Bard Access Systems, Inc, 5425 Amelia Earhart Dr, Salt Lake City UT 84116-3713
Source
USFDA
30 Events
Recall of Device Recall Bard PEG
Recall of Device Recall FASTRAC Guidewire Gastric Access Port
Recall of Device Recall Bard PEG
Recall of Device Recall Ponsky PEG
Recall of Device Recall Bard Deluxe Guidewire PEG
Recall of Device Recall Ponsky Deluxe "Pull" PEG
Recall of Device Recall Bard Deluxe Guidewire PEG
Recall of Device Recall Ponsky Deluxe "Pull" PEG
Recall of Device Recall FASTRAC "Pull" Gastric Access Port
Recall of Device Recall FASTRAC "Pull" Gastric Access Port
Recall of Device Recall FASTRAC "Pull" Gastric Access Port
Recall of Device Recall FASTRAC "Pull" Gastric Access Port
Recall of Device Recall FASTRAC "Pull" Gastric Access Port
Recall of Device Recall FASTRAC "Pull" Gastric Access Port
Recall of Device Recall FASTRAC "Pull" Gastric Access Port
Recall of Device Recall FASTRAC "Pull" Gastric Access Port
Recall of Device Recall FASTRAC "Pull" Gastric Access Port
Recall of Device Recall FASTRAC "Pull" Gastric Access Port
Recall of Device Recall FASTRAC "Pull" Gastric Access Port
Recall of Device Recall FASTRAC "Pull" Gastric Access Port
Recall of Device Recall Ponsky PEG
Recall of Device Recall FASTRAC "Pull" Gastric Access Port
Recall of Device Recall FASTRAC "Pull" Gastric Access Port
Recall of Device Recall FASTRAC "Pull" Gastric Access Port
Recall of Device Recall Bard PEG
Recall of Device Recall Ponsky PEG
Recall of Device Recall Ponsky PEG
Recall of Device Recall Gauderer Genie II PEG
Recall of Device Recall Gauderer Genie II PEG
Recall of BARD Access Systems
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30 devices in the database
Device Recall Bard PEG
Model / Serial
Lots: 43DQA032 , 43FQA161, 43GQA068, 43HQA056, 43IQA058, 43JQA059, 43KQA075, 43LQA078, HURA1477, HURB2561, HURD0513, HURD1835, HURE2826, HURF0409, HURG1390, HURH0876, HURJ0544, HURJ0545, HURJ1447, HURJ1448, HUSD0101, HUSD1943, HUSE1509, HUSF1754.
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide, including USA, Belgium, Canada, Australia, and Japan.
Product Description
Bard Access Systems, Inc., Bard* PEG (Percutaneous Endoscopic Gastrostomy) Safety System - "Guidewire", REF 006036, 20F, Sterile.
Device Recall FASTRAC Guidewire Gastric Access Port
Model / Serial
Lots: HURD0641, HURE2819, HURJ2187, HUSA0274, HUSD0038.
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide, including USA, Belgium, Canada, Australia, and Japan.
Product Description
Bard Access Systems, Inc., FASTRAC Guidewire Gastric Access Port Kit, REF 005739, 20F, Sterile.
Device Recall Bard PEG
Model / Serial
Lots: 43FQAO78, 43FQA186, 43GQA080, 43HQA083, 43lQA092, 43JQA083,43KQA197, 43LQA202, HURA1457, HURB2555, HURD1301, HURD1995, HURE2973, HURE3447, HURE3448, HURF0572, HURG0273, HURH0036, HURH1222, HURJ0797, HURK1562, HUSA0504, HUSB1435, HUSC0155, HUSD0380, HUSD2072, HUSE0001, HUSF0580.
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide, including USA, Belgium, Canada, Australia, and Japan.
Product Description
Bard Access Systems, Inc., Bard* PEG (Percutaneous Endoscopic Gastrostomy) Safety System - "Guidewire" REF 003030, 20F, Sterile.
Device Recall Ponsky PEG
Model / Serial
Lots: 43EQA085, 43FQA077, 43FQA177, 43GQA078, 43GQA079, 43GQA177,43GQA178, 43IQA091, 43IQA177, 43LQA109, HURA1456, HURB1687, HURB1688, HURB2446, HURB4538, HURD0616, HURD1300, HURD1993, HURE0754, HURE3446, HURF0571, HURH0035, HURH0293, HURH0685, HURH1221, HURI0670, HURJ0796, HURK1561, HUSA0503, HUSC0636, HUSD0279, HUSD2071, HUSF2001, HUSG0586.
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide, including USA, Belgium, Canada, Australia, and Japan.
Product Description
Bard Access Systems, Inc., Ponsky* PEG (Percutaneous Endoscopic Gastrostomy) Safety System - "Pull", REF 003029, 20F, Sterile.
Device Recall Bard Deluxe Guidewire PEG
Model / Serial
Lots: 43DQA112, 43EQA079, 43EQA080, 43FQA074, 43FQA097, 43GQA075, 43GQA076, 43GQA194, 43HQA079, 43HQA080, 43IQA180, 43KQA114, 43KQA115, 43LQA107.
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide, including USA, Belgium, Canada, Australia, and Japan.
Product Description
Bard Access Systems, Inc., Bard* Deluxe Guidewire PEG (Percutaneous Endoscopic Gastrostomy) System with Soft Silicone Retention Dome, Sterile, Rx only, REF 000793, 20F.
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