ARROW recallZ-1366-2019 · Arrow International Inc · initiated Dec 13, 2018
Terminated
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
Kits labeled as containing a 40 cm PICC may contain a 50 cm PICC, and kits labeled as containing a 50 cm PICC may contain a 40 cm PICC
FDA root cause category: Employee error
What the company is doing
Arrow International initiated recall notification letter on 13th December 2018 via FedEx 2-day mail describing problem ,health risk and action to take:, immediately discontinue use and quarantine the products. Complete the enclosed Acknowledgement Form as soon as possible indicating whether you do or do not have stock and fax it to 1-855-419-8507 or email to [email protected]. A customer service representative will contact you with a Return Goods Authorization (RGA) number and provide instructions for the return of products.
Recall details
- Recall number
- Z-1366-2019
- Status
- Terminated
- Initiated by the company
- Dec 13, 2018
- Recalling firm
- Arrow International Inc
- Quantity
- 963 units (US) in total
- Product code
- LJS
- FDA submissions
- K153487
- Distribution
- US Nationwide Distribution
Product description
Arrow PICC powered by Arrow VPS Precision Stylet Product Code:CDC-44052-VPS2 Product Usage: The Arrow Pressure Injectable PICC is indicated for short-term or longterm peripheral access to the central venous system for intravenous therapy, blood sampling, infusion, pressure injection of contrast media and allows for central venous pressure monitoring. The maximum pressure of pressure injector equipment used with the pressure injectable PICC may not exceed 300 psi.
Code information (models, lots, serial numbers)
Lot/Batch Number: 23F18B0581 GTIN:20801902120704
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- ARROW IPN037308Teleflex Incorporated · Catheter,intravascular,therapeutic,long-term greater than 30 days1 recall0 reports
Product lines
Other devices under the same FDA submission
28 devices cleared under K153487 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.
- ARROW IPN928638Teleflex Incorporated · Catheter, intravascular, therapeutic, long-term greater than 30 days2 recalls0 reports
- ARROW IPN037306Teleflex Incorporated · Catheter,intravascular,therapeutic,long-term greater than 30 days1 recall25 reports
- ARROW IPN037302Teleflex Incorporated · Catheter, intravascular, therapeutic, long-term greater than 30 days1 recall4 reports
- ARROW IPN038495Teleflex Incorporated · INTRODUCER, CATHETER1 recall1 report
- ARROW IPN928635Teleflex Incorporated · Catheter, intravascular, therapeutic, long-term greater than 30 days1 recall1 report
- ARROW IPN037300Teleflex Incorporated · Catheter,intravascular,therapeutic,long-term greater than 30 days1 recall0 reports
- ARROW IPN928633Teleflex Incorporated · Catheter, intravascular, therapeutic, long-term greater than 30 days1 recall0 reports
- ARROW IPN928636Teleflex Incorporated · Catheter, intravascular, therapeutic, long-term greater than 30 days1 recall0 reports
- ARROW IPN037301Teleflex Incorporated · Catheter, intravascular, therapeutic, long-term greater than 30 days26 reports
- ARROW IPN037300Teleflex Incorporated · Catheter, intravascular, therapeutic, long-term greater than 30 days18 reports
- ARROW IPN037304Teleflex Incorporated · Catheter, intravascular, therapeutic, long-term greater than 30 days12 reports
- ARROW IPN037308Teleflex Incorporated · Catheter, intravascular, therapeutic, long-term greater than 30 days10 reports
Other products in the same recall event
The FDA groups related products into one recall event (event 82506).
- Z-1365-2019 · TerminatedArrow PICC powered by Arrow VPS Precision Stylet Product Code:CDC-45052-VPS2 Product Usage: The Arrow Pressure Injectable PICC is indicated for short-term or longterm peripheral a…
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 16, 2026. Text above is shown as published by the FDA.
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