Z-0639-04

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

Name: Z-0639-04 Two Lumen 14F Hemodialysis Catheter Kits/Sets with Blue FlexTip Arrowg+ard Blue Curved Catheter for high...
Creator: Arrow International Inc
Published: 2004-02-18
License: https://open.fda.gov/license/

Arrow International LLC (subsidiary of Teleflex Incorporated) / initiated 2004-02-18 / Terminated

FDA source

Arrow International Inc began a recall of Two Lumen 14F Hemodialysis Catheter Kits/Sets with Blue FlexTip Arrowg+ard Blue Curved Catheter for high Volume Ifusions on 2004-02-18. The reason FDA records is "catheter slips out of the suture wing during use". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0639-04
Status: Terminated
Initiated: 2004-02-18
Posted: 2004-07-20
Terminated: 2004-08-19
Recalling firm: Arrow International LLC (subsidiary of Teleflex Incorporated)
Product: Two Lumen 14F Hemodialysis Catheter Kits/Sets with Blue FlexTip Arrowg+ard Blue Curved Catheter for high Volume Ifusions
Product code: MPB Catheter, Hemodialysis, Non-Implanted
Reason for recall: catheter slips out of the suture wing during use.
FDA root cause: Other
Action: 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.
Quantity in commerce: 6610 UNITS
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 codes and lots: 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 code MPB

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)