Recalls / —

—#31756

Product

Two Lumen 14F Hemodialysis Catheter Kits/Sets with Blue FlexTip Arrowg+ard Blue Curved Catheter for high Volume Ifusions

FDA product code

MPB — Catheter, Hemodialysis, Non-Implanted

Device class

Class 2

Medical specialty

Gastroenterology, Urology

510(k) numbers

K991431, K993933

Affected lot / code info

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.

Why it was recalled

catheter slips out of the suture wing during use.

Root cause (FDA determination)

Other

Action the firm took

The recalling firm issued a recall letter dated 2/18/04 to their direct accounts informing them of the problem and the need to return the product.

Recalling firm

Firm

Arrow International Inc

Address

2400 Bernville Rd, Reading, Pennsylvania 19605-9607

Distribution

Distribution pattern

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.

Timeline

Recall initiated

2004-02-18

Posted by FDA

2004-07-20

Terminated

2004-08-19

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #31756. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.