Arrow ErgoPack Pressure Injectable One-Lumen PICC, REF… recallZ-2590-2023 · ARROW INTERNATIONAL Inc. · initiated Aug 10, 2023
Class II Open, Classified All recalls posted in September 2023
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
This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits.
FDA root cause category: Under Investigation by firm
What the company is doing
Teleflex/Arrow International issue an URGENT MEDICAL DEVICE RECALL notice on 08/10/2023 by FedEx 2nd day mail. The letter explained the problem, risk to patient, and requested the following actions: Medical facilities: Immediately cease use and distribution of affected product and quarantine for return. Distributors: Immediately cease use and distribution of affected product and quarantine for return. Provide a copy of this recall notice to all customers who have received impacted product. Request they complete the Acknowledgement Form and return it to you. Firm is requesting return of the affected product.
Recall details
- Recall number
- Z-2590-2023
- Recall class
- Class II
- Status
- Open, Classified
- Initiated by the company
- Aug 10, 2023
- Posted by the FDA
- Sep 15, 2023
- Recalling firm
- ARROW INTERNATIONAL Inc.
- Quantity
- 190 units
- Product code
- LJS
- FDA submissions
- K073451
- Distribution
- US Nationwide distribution.
Product description
Arrow ErgoPack Pressure Injectable One-Lumen PICC, REF CDC-05541-HPK1A; catheter, intravascular
Code information (models, lots, serial numbers)
Batch/Lot number 13F22J0617
Other devices under the same FDA submission
3 devices cleared under K073451 — 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 IPN033364Teleflex Incorporated · Catheter, intravascular, therapeutic, long-term greater than 30 days4 reports
- ARROW IPN032720Teleflex Incorporated · Catheter,intravascular,therapeutic,long-term greater than 30 days1 report
- ARROW IPN033362Teleflex Incorporated · Catheter,intravascular,therapeutic,long-term greater than 30 days1 report
Other products in the same recall event
The FDA groups related products into one recall event (event 92850).
- Z-2591-2023 · Open, ClassifiedArrow ErgoPack, Pressure Injectable Two-Lumen PICC pre-loaded with Arrow VPS Stylet, REF CDC-35552-VPS; Catheter: Percutaneous, implanted, long-term intravascular catheter
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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