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Devices
Device Recall PeelAway Introducer set
Model / Serial
Lot Numbers: 1923714, 1923715, 1923718, 1923719, 1923721, 1923722, 1923723, 1928888, 1928889, 1928891, 1928892, 1928893, 1928894, 1928895, 1928896, 1928897, 1935086, 1935087, 1935089, 1935090, 1935095, 1958841, 1958843, 1958844, 1958847, 1958848, 1958849, 1958850, 1958851 and 1972150.
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution- including USA and countries of Argentina, Australia, Canada, Chile, Denmark, Japan, New Zealand and Singapore.
Product Description
Peel-Away Introducer set, 7.0 FR, Catheter introducer, includes sheath: 7.0 FR., 15.5 CM long, Wire: .038" DIA., 50 CM long, 3 MM J needle: 18 ga., 7.0 cm long. Accepts devices up to 7.0 French., sterile; Catalog Number: C-PLI-7.0-38. Cook Inc., Bloomington, IN 47404
Manufacturer
Cook, Inc.
1 Event
Recall of Device Recall PeelAway Introducer set
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Manufacturer
Cook, Inc.
Manufacturer Address
Cook, Inc., 750 Daniels Way, Bloomington IN 47404-9120
Source
USFDA
8 devices with a similar name
Learn more about the data
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Device Recall PeelAway Introducer Set
Model / Serial
Lot Numbers: F2143720, F2143731, F2144828, F2147203, F2147788 and F2148621.
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution- including USA and countries of Argentina, Australia, Canada, Chile, Denmark, Japan, New Zealand and Singapore.
Product Description
Peel-Away Introducer set, 7.0 FR; Catheter introducer, includes sheath: 7.0 FR., 15.5 CM long, Wire: .035" DIA., 50 CM long, 3 MM J needle: 18 ga., 7.0 cm long. Accepts devices up to 7.0 French,sterile, Catalog Number: C-PLI-7.0-35. Cook Inc., Bloomington, IN 47404
Manufacturer
Cook, Inc.
Device Recall PeelAway Introducer Set
Model / Serial
Lot Numbers: F2121224 and F2143768.
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution- including USA and countries of Argentina, Australia, Canada, Chile, Denmark, Japan, New Zealand and Singapore.
Product Description
Peel-Away Introducer set, 7.0 FR, Catheter introducer, includes sheath: 7.0 FR., 15.5 CM long, Wire: .035" DIA., 50 CM long, 3 MM J needles: 18 ga., 7.0 cm long. Accepts devices up to 7.0 French, sterile, Catalog Number: C-PLI-7.0-35-X-1. Cook Inc., Bloomington, IN 47404
Manufacturer
Cook, Inc.
Device Recall PeelAway Introducer set
Model / Serial
Lot Number: F2118728.
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution- including USA and countries of Argentina, Australia, Canada, Chile, Denmark, Japan, New Zealand and Singapore.
Product Description
Peel-Away Introducer set, Catheter introducer, sterile; Catalog Number: C-PLI-7.0-38-CPC-072491. William Cook Europe A/S, Cook Inc., Bloomington, IN 47404.
Manufacturer
Cook, Inc.
Device Recall PeelAway Introducer Set
Model / Serial
Lot Numbers: F2114474 and F2120414.
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution- including USA and countries of Argentina, Australia, Canada, Chile, Denmark, Japan, New Zealand and Singapore.
Product Description
Peel-Away Introducer set, 7.0 FR; includes sheath: 7.0 FR., Catheter introducer, 9 CM long, Wire: .035" DIA., 30 CM long, 3 MM J needle: 18 ga., 4.0 cm long. Accepts devices up to 7.0 French., sterile; Catalog Number: C-PLIP-7.0-35. Cook Inc., Bloomington, IN 47404
Manufacturer
Cook, Inc.
Device Recall PeelAway Introducer set
Model / Serial
Lot Number: F2143777.
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution- including USA and countries of Argentina, Australia, Canada, Chile, Denmark, Japan, New Zealand and Singapore.
Product Description
Peel-Away Introducer set, 7.0 FR; Catheter introducer, includes sheath: 7.0 FR., 15.5 CM long, Wire: .035" DIA., 50 CM long. Accepts devices up to 7.0 French., sterile; Catalog Number: C-PLV-7.0-35. Cook Inc., Bloomington, IN 47404.
Manufacturer
Cook, Inc.
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