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Arrow ErgoPack, Pressure Injectable Arrowg+ard Blue Advance… recallZ-0001-2024 · ARROW INTERNATIONAL Inc. · initiated Aug 10, 2023

Class I Open, Classified All recalls posted in October 2023

Is my device affected?

  1. 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.
  2. 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.
  3. 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-0001-2024
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
1173 units
Product code
LJS
FDA submissions
K153487
Distribution
US

Product description

Arrow 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-Term Intravascular Catheter Stylet: Diagnostic Intravascular Catheter

Code information (models, lots, serial numbers)

Batch/Lot number 33F23B0781

Other devices under the same FDA submission

29 devices cleared under K153487 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Other products in the same recall event

The FDA groups related products into one recall event (event 93014).

Sources and updates

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