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Devices
Device Recall Arrow Select Kits (ASK), Maximal Barrier Precautions Kits (CDC), and Arterial Catheterization Kit
Model / Serial
Product Codes: ASK-11142-MGH4, ASK-04020-UR1, CDC-45552-HPK1A, CDC-35052-VPS, ASK-09903-MGH3, CDC-02041-MK1A , CDC-45041-VPS, ASK-09903-FAM, CDC-05052-HPK1A, NA-04020-X1A, CDC-21242-X1A, ASK-04020-MI, ASK-04001-UOC, MSO-45703-AHS, CDC-45541-HPK1A , CDC-35052-HPK1A, ASK-21142-SG1, MSO-24703-AHS, MSO-29802-AHS, ASK-12702-SMCC, CDC-25142-X1A; Lot Numbers: 23F14H0501, 23F14J0287, 23F14J0619, 23F14J1390, 23F14H0918, 23F14J0613, 23F14J1433, 23F14K0115, 23F14J0617, 23F14J0356, 23F14K0114, 23F14J0554, 23F14J1134, 23F14J1551, 23F14J0508, 23F14J1142, 23F14J1516, 23F14J1355, 23F14H0577, 23F14J0237, 23F14H1120
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
US (nationwide) and PR.
Product Description
Arrow Select Kits (ASK), Maximal Barrier Precautions Kits (CDC) and Arterial Catheterization Kit (NA) with Biopatch Dressing
Manufacturer
Arrow International Inc
1 Event
Recall of Device Recall Arrow Select Kits (ASK), Maximal Barrier Precautions Kits (CDC), and Arterial Catheterization Kit
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Manufacturer
Arrow International Inc
Manufacturer Address
Arrow International Inc, 2400 Bernville Road, Reading PA 19605
Manufacturer Parent Company (2017)
Teleflex Incorporated
Source
USFDA
Language
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