Arrowg+ard Blue Two Lumen CVC Super Kit, Catalog number… recallZ-0059-05 · Arrow International Inc · initiated Sep 27, 2004
Terminated All recalls posted in October 2004
Is my device affected?
- 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.
- 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.
- 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
Labeling error. Kits contains the correct components for AK-42802-SK but may have a package label indicating that it is product number AK-22802-SK
FDA root cause category: Other
What the company is doing
The recalling firm issued a recall letter dated 9/27/04 to their accounts informing them of the problem and the need to return the product.
Recall details
- Recall number
- Z-0059-05
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Sep 27, 2004
- Posted by the FDA
- Oct 28, 2004
- Recalling firm
- Arrow International Inc
- Quantity
- 290 kits
- Product code
- FOZ
- FDA submissions
- K993691
- Distribution
- The products were shipped to distributors in KS and VA, medical facilities in AR, FL, and GA, and a sales representative in FL.
Product description
Arrowg+ard Blue Two Lumen CVC Super Kit, Catalog number AK-22802-SK. The kit actually contains Arrowg+ard Blue Plus Two Lumen CVC Super Kit. Catalog number AK-42802-SK, 8 Fr x 16 cm Two Lumen Arrowg+ard Blue Plus Catheters. The plus indicates that the line extension clamps are attached to the catheters.
Code information (models, lots, serial numbers)
Lot number RF4066579
Other devices under the same FDA submission
14 devices cleared under K993691 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- ARROW IPN037069Teleflex Incorporated · Catheter,intravascular,therapeutic,short-term less than 30 days1 recall0 reports
- ARROW IPN037833Teleflex Incorporated · Catheter,intravascular,therapeutic,short-term less than 30 days1 recall0 reports
- ARROW IPN037836Teleflex Incorporated · Catheter,intravascular,therapeutic,short-term less than 30 days1 recall0 reports
- ARROW IPN038392Teleflex Incorporated · Catheter, intravascular, therapeutic, short-term less than 30 days1 recall0 reports
- ARROW IPN055804Teleflex Incorporated · Catheter, intravascular, therapeutic, short-term less than 30 days1 recall0 reports
- ARROW IPN916999Teleflex Incorporated · Catheter, intravascular, therapeutic, short-term less than 30 days1 recall0 reports
- ARROW IPNB00080Teleflex Incorporated · Catheter, intravascular, therapeutic, short-term less than 30 days1 recall0 reports
- ARROW IPN030243Teleflex Incorporated · Catheter, intravascular, therapeutic, short-term less than 30 days20 reports
- ARROW IPN030195Teleflex Incorporated · Catheter,intravascular,therapeutic,short-term less than 30 days3 reports
- ARROW IPN030240Teleflex Incorporated · Catheter,intravascular,therapeutic,short-term less than 30 days1 report
- ARROW IPN030231Teleflex Incorporated · Catheter, intravascular, therapeutic, short-term less than 30 days1 report
- ARROW IPN037089Teleflex Incorporated · Catheter,intravascular,therapeutic,short-term less than 30 days1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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