The CG+ Arrow PIC Catheters permit venous access to the… recallZ-1705-2017 · Arrow International Inc · initiated Mar 3, 2017
Class II Terminated All recalls posted in March 2017
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
Arrow International, Inc. notified its customers who received the affected Antimicrobial/Antithrombogenic PICC Kits, that the kits were being recalled due to a labeling error. The lidstock on some of the kits reads CDC-45541-HPK1A, while the banner card on the side of the kit reads CDC-45052-HPK1A. Other kits may list CDC-45052-HPK1A on the lidstock and CDC-45541-HPK1A on the banner card. The affected lot numbers are 23F16C0851, 23F16A0727, and 23F16C0844.
FDA root cause category: Under Investigation by firm
What the company is doing
Arrow International mailed an Urgent Medical Device Recall Notification letter to affected customers on March 7, 2017, to inform them of the issue. The notification informs customers to discontinue use and quarantine any products identified with the specific lot numbers. Customers are asked to complete the enclosed Recall Acknowledgement Form for product return. For further questions, please call (866) 246-6990.
Recall details
- Recall number
- Z-1705-2017
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Mar 3, 2017
- Posted by the FDA
- Mar 8, 2017
- Recalling firm
- Arrow International Inc
- Quantity
- 1,351 catheters
- Product code
- LJS
- FDA submissions
- K112896
- Distribution
- US Distribution
Product description
The CG+ Arrow PIC Catheters permit venous access to the central circulation through a peripheral vein.
Code information (models, lots, serial numbers)
Device Listing Number: D149129 Lot Numbers: 23F16C0851, 23F16A0727 and 23F16C0844
Other devices under the same FDA submission
33 devices cleared under K112896 — 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 IPN924180Teleflex Incorporated · Catheter, intravascular, therapeutic, long-term greater than 30 days2 recalls0 reports
- ARROW IPN924181Teleflex Incorporated · Catheter, intravascular, therapeutic, long-term greater than 30 days2 recalls0 reports
- ARROW IPN924157Teleflex Incorporated · Catheter, intravascular, therapeutic, long-term greater than 30 days1 recall5 reports
- ARROW IPN924159Teleflex Incorporated · Catheter, intravascular, therapeutic, long-term greater than 30 days1 recall4 reports
- ARROW IPN924178Teleflex Incorporated · Catheter, intravascular, therapeutic, long-term greater than 30 days1 recall2 reports
- ARROW IPN919553Teleflex Incorporated · Catheter, intravascular, therapeutic, long-term greater than 30 days1 recall0 reports
- ARROW IPN928812Teleflex Incorporated · Catheter, intravascular, therapeutic, long-term greater than 30 days1 recall0 reports
- ARROW IPN929205Teleflex Incorporated · Catheter, intravascular, therapeutic, long-term greater than 30 days1 recall0 reports
- ARROW IPN930518Teleflex Incorporated · Catheter, intravascular, therapeutic, long-term greater than 30 days1 recall0 reports
- ARROW IPN033540Teleflex Incorporated · Catheter,intravascular,therapeutic,long-term greater than 30 days12 reports
- ARROW IPN033516Teleflex Incorporated · Catheter, intravascular, therapeutic, long-term greater than 30 days9 reports
- ARROW IPN033506Teleflex Incorporated · Catheter, intravascular, therapeutic, long-term greater than 30 days3 reports
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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