ARROWg+ard Blue PLUS Pressure Injectable Two-Lumen CVC Kit.… recallZ-1082-2015 · Arrow International Inc · initiated Jan 2, 2015
Class II Terminated All recalls posted in February 2015
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
Foreign material found within the kits. The foreign material, white or black particles and/or thread, is visible and can beidentified by the user.
FDA root cause category: Process control
What the company is doing
An urgent Medical Device Recall Notification, dated January 2, 2015, was sent to end users requesting they check their inventory and return affected product per Arrow's instructions.
Recall details
- Recall number
- Z-1082-2015
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Jan 2, 2015
- Posted by the FDA
- Feb 10, 2015
- Recalling firm
- Arrow International Inc
- Quantity
- 1195
- Product code
- FOZ
- FDA submissions
- K071538
- Distribution
- Nationwide
Product description
ARROWg+ard Blue PLUS Pressure Injectable Two-Lumen CVC Kit. The Multiple-Lumen Catheter permits venous access to the central circulation by way of the femoral jugular, or subclavian veins.
Code information (models, lots, serial numbers)
product number CDC-42802-P1A, lot number 23F14A0063
Other devices under the same FDA submission
231 devices cleared under K071538 — 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 IPN038522Teleflex Incorporated · Catheter, intravascular, therapeutic, short-term less than 30 days3 recalls1 report
- ARROW IPN931283Teleflex Incorporated · Catheter, intravascular, therapeutic, short-term less than 30 days3 recalls0 reports
- ARROW IPN931284Teleflex Incorporated · Catheter, intravascular, therapeutic, short-term less than 30 days3 recalls0 reports
- ARROW IPN931286Teleflex Incorporated · Catheter, intravascular, therapeutic, short-term less than 30 days3 recalls0 reports
- ARROW IPN036445Teleflex Incorporated · Catheter,intravascular,therapeutic,short-term less than 30 days2 recalls8 reports
- ARROW IPN915628Teleflex Incorporated · Catheter, intravascular, therapeutic, short-term less than 30 days2 recalls5 reports
- ARROW IPN915630Teleflex Incorporated · Catheter, intravascular, therapeutic, short-term less than 30 days2 recalls2 reports
- ARROW IPN036474Teleflex Incorporated · Catheter,intravascular,therapeutic,short-term less than 30 days2 recalls1 report
- ARROW IPN904896Teleflex Incorporated · Catheter,intravascular,therapeutic,short-term less than 30 days2 recalls1 report
- ARROW IPN038523Teleflex Incorporated · Catheter, intravascular, therapeutic, short-term less than 30 days2 recalls1 report
- ARROW IPN055818Teleflex Incorporated · Catheter, intravascular, therapeutic, short-term less than 30 days2 recalls1 report
- ARROW IPN055820Teleflex Incorporated · Catheter, intravascular, therapeutic, short-term less than 30 days2 recalls1 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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