Arrow ErgoPack Complete, Pressure Injectable Arrowg+ard… recallZ-0002-2024 · ARROW INTERNATIONAL Inc. · initiated Aug 10, 2023
Class I Open, Classified All recalls posted in October 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-0002-2024
- Recall class
- Class I (most serious)
- Status
- Open, Classified
- Initiated by the company
- Aug 10, 2023
- Posted by the FDA
- Oct 5, 2023
- Recalling firm
- ARROW INTERNATIONAL Inc.
- Quantity
- 180 units
- Product code
- FOZ
- FDA submissions
- K071538
- Distribution
- US
Product description
Arrow ErgoPack Complete, Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC, REF CDC-42854- PCN1A; catheter, intravascular, therapeutic, long-term greater than 30 days
Code information (models, lots, serial numbers)
Batch/Lot number 33F23B0723
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
Other products in the same recall event
The FDA groups related products into one recall event (event 93014).
- Z-0001-2024 · Open, ClassifiedArrow ErgoPack, Pressure Injectable Arrowg+ard Blue Advance Two-Lumen PICC pre-loaded with Arrow VPS Precision Stylet, REF CDC-45552-VPS2; Catheter: Percutaneous Implanted Long-Ter…
- Z-0003-2024 · Open, ClassifiedArrow Pressure Injectable Arrowg+ard Blue Plus Four-Lumen CVC, REF CDC-45854-P1A; catheter, intravascular, therapeutic, long-term greater than 30 days
- Z-0004-2024 · Open, ClassifiedArrow ErgoPack Pressure Injectable Arrowg+ard Blue Advance Three-Lumen PICC pre-loaded with Arrow VPS TipTracker Stylet, REF CDC-45563-TTS; catheter, intravascular, therapeutic, lo…
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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