Devices

Device Recall Two Lumen 14F Hemodialysis Catheter Kits/Sets

Model / Serial
Product number AK-22142-CF Lot numbers RF2035008, RF2067620, RF2100365, RF3023691, RF3045916, RF3078012, RF3089042, RF3099786, RF3121691, and RF3122085. Product number AK-22142-CFSP Lot numbers RF2046619, RF2046669, RF3099895, and RF3111053. Product number AK-22142-F Lot numbers RF1105891, RF2100885, RF3088793, RF3089028, RF3089202, RF3099359, RF3100354, RF4012646. Product number AK-25142-CF Lot number RF1080802, RF1094019, RF2010218, RF2067624, RF2100633, RF2100886, RF3067453, RF3088794, RF3099633, RF3100446, and RF3121805. Product number AK-25142-CFSP Lot numbers RF2010219, RF2046670, RF3100573, and RF3111264. Product number AK-25142-F Lot numbers RF1104566, RF3024351, RF3034977, RF3056501, RF3088861, RF3089029, RF3099313, and RF3100355. Product number CS-22142-CF Lot numbers RF1028262, RF1033063, RF1105890, RF2099516, RF2111093, RF3013358, RF3077978, RF3088513, RF3099272, and RF3100452. Product number CS-22142-F Lot numbers RF1033064, RF2100484, RF3045575, RF3088456, and RF3051547. Product number CS-25142-CF Lot numbers RF1082563, RF1104918, RF1105889, RF2089343, RF2100890, RF2111125, RF3056376, RF3067264, and RF3099410. Product number CS-25142-F Lot numbers RF1104919, RF2111094, RF2111192, RF2111673, RF3023765, RF3035176, RF3045410, RF3056617, RF3099369, RF3121572, and RF4012292.Product number CS-26142-F Lot numbers RF2111134, RF2111290, RF3078240, RF3088795, RF3099586, RF3100056, RF3100272, RF3111001, RF3111434, and RF3121623.
Product Classification
Gastroenterology-Urology Devices
Device Class
2
Implanted device?
No
Distribution
The product was shipped to hospitals, medical supply companies, and sales representatives nationwide. Products were also shipped to England, Belgium, Germany, Greece, Sweden, Ukraine, France, Taiwan, Australia, Netherlands, and Denmark.
Product Description
Two Lumen 14F Hemodialysis Catheter Kits/Sets with Blue FlexTip Arrowg+ard Blue Curved Catheter for high Volume Ifusions
Manufacturer
Arrow International Inc
1 Event
- Recall of Device Recall Two Lumen 14F Hemodialysis Catheter Kits/Sets

Manufacturer

Arrow International Inc

Manufacturer Address
Arrow International Inc, 2400 Bernville Rd, Reading PA 19605-9607
Manufacturer Parent Company (2017)
Teleflex Incorporated
Source
USFDA

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