Arrow EVOLUTION Pressure Injectable PICC with Chlorag+ard… recallZ-2698-2017 · Arrow International Inc · initiated Jun 12, 2017
Class II Terminated All recalls posted in June 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 is recalling additional lots that were identified as part of an active recall. Arrow is recalling the affected product due to the possibility that the catheter peel-away component hub tabs may prematurely detach when the practitioner begins to peel apart the sheath body from the catheter.
FDA root cause category: Device Design
What the company is doing
Teleflex/Arrow International mailed an Urgent Medical Device Recall Notification Letter to affected customers on 06/12/2017 to inform them of the issue. Arrow requested that customers examine their inventory immediately for the affected lots and discontinue use and quarantine any products with the associated product codes identified in the notice and complete the Recall Acknowledgement Form and fax back to the number included in the notice.
Recall details
- Recall number
- Z-2698-2017
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Jun 12, 2017
- Posted by the FDA
- Jun 27, 2017
- Recalling firm
- Arrow International Inc
- Quantity
- 9,037 units in the U.S. and 4,500 units internationally
- Product code
- LJS
- FDA submissions
- K112896
- Distribution
- Distributed to SC, AL, NJ, IN, MA, GA, CA, PA, AZ, VA , WA and Bangkok
Product description
Arrow EVOLUTION Pressure Injectable PICC with Chlorag+ard Antimicrobial and Antithrombogenic Technology
Code information (models, lots, serial numbers)
Device Listing # D149129 Material # ASK-45552-RWJ4 PR-45552-HPHNL
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
Other products in the same recall event
The FDA groups related products into one recall event (event 77604).
- Z-2699-2017 · TerminatedArrow Glide Thru Peel-Away Sheath/Dilator Introducer
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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