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Devices
Device Recall Introducer catheter
Model / Serial
Catalog Number 384224, Lot Number 3349840.
Product Classification
General Hospital and Personal Use Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide. Foreign distribution to Australia and Brazil. No government or military direct accounts.
Product Description
BD First PICC Introsyte-N, 1.9Fr. x 50cm Single Lumen Procedure Kit.
Manufacturer
Becton Dickinson Infusion Therapy
1 Event
Recall of Device Recall Introducer catheter
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Manufacturer
Becton Dickinson Infusion Therapy
Manufacturer Address
Becton Dickinson Infusion Therapy, 9450 South State Street, Sandy UT 84070
Source
USFDA
3 devices with a similar name
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Device Recall Introducer catheter
Model / Serial
Catalog Number 380402, Lot Numbers 3356877, 3356485, 3352218.
Product Classification
General Hospital and Personal Use Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide. Foreign distribution to Australia and Brazil. No government or military direct accounts.
Product Description
BD Introsyte-N Precision Introducer in 1.9Fr. Bulk, Non-sterile.
Manufacturer
Becton Dickinson Infusion Therapy
Device Recall Introducer catheter
Model / Serial
Ref. No. 680124, Lot No''s. 406462 and 311197
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Domestic distribution: WI. International distribution: Puerto Rico, Virgin Islands. There were no military or VA facilities.
Product Description
BD Exacta 8.5 Fr Percutaneous Sheath Introducer Tray
Manufacturer
Becton Dickinson Infusion Therapy
Device Recall Introducer catheter.
Model / Serial
Ref. No. 680128, Lot No. 407458
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Domestic distribution: WI. International distribution: Puerto Rico, Virgin Islands. There were no military or VA facilities.
Product Description
BD Exacta 6Fr Percutaneous Sheath Introducer Tray.
Manufacturer
Becton Dickinson Infusion Therapy
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