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Device Recall PORTACATH
Model / Serial
a. Item No. 21-4071-24 (Lot No. 86X046, 87X050); b. Item No. 21-8066-24 (Lot No. 87X178); c. Item No. 21-8068-24 (Lot No. 87X179)
Product Classification
General Hospital and Personal Use Devices
Device Class
2
Implanted device?
Yes
Distribution
Worldwide Distribution. US nationwide including Puerto Rico, Austria, Bahamas, Belgium, Dominican Republic, Netherlands, Spain, and Turks and Caicos.
Product Description
PORT-A-CATH II PS/Titan, Tray PAC II. Labeled as: || a. VEN LP, PU, 2.6MM, UL, 8.5FR/INTRO (1/EA); || b. DL, LP, PU, 2.2MM, WING-LOCK, 7FR/INTRO (1/EA); || c. DL, LP, PU, 3.2MM, WING-LOCK, 10FR/INTRO (1/EA)
Manufacturer
Smiths Medical ASD Inc.
1 Event
Recall of Device Recall PORTACATH
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Manufacturer
Smiths Medical ASD Inc.
Manufacturer Address
Smiths Medical ASD Inc., 6000 Nathan Ln N, Minneapolis MN 55442-1690
Manufacturer Parent Company (2017)
Smiths Group Plc
Source
USFDA
One device with a similar name
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Device Recall PortACath Tray
Model / Serial
Model number: 58647B, Lot number: 187175, Exp. Date: 12/1/2015.
Product Classification
General and Plastic Surgery Devices
Device Class
2
Implanted device?
No
Distribution
Distributed in the states of AR, AZ, FL, GA, IA, IL, KY, MA, MN, NC, NY, OH, TN, TX, and VA.
Product Description
Port-A-Cath Tray, Stage One: Sterile Single Use, Stage Two: Clean Ready to Use, Latex Free, 20/case, Medical Action Industries, Inc, Arden, NC.
Manufacturer
Medical Action Industries Inc
Language
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