Skip to content

Two Lumen 14F Hemodialysis Catheter Kits/Sets with Blue… recallZ-0639-04 · Arrow International Inc · initiated Feb 18, 2004

Terminated All recalls posted in July 2004

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Arrow International Inc or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

catheter slips out of the suture wing during use.

FDA root cause category: Other

What the company is doing

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.

Recall details

Recall number
Z-0639-04
Recall class
Not yet classified by the FDA
Status
Terminated
Initiated by the company
Feb 18, 2004
Posted by the FDA
Jul 20, 2004
Recalling firm
Arrow International Inc
Quantity
6610 UNITS
Product code
MPB
FDA submissions
K991431, K993933
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

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

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.

Other devices under the same FDA submission

57 devices cleared under K991431, K993933 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page