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Arrow Pressure Injectable PICC Powered by Arrow VPS Stylet… recallZ-1494-2014 · Arrow International Inc · initiated Mar 24, 2014

Class II Terminated All recalls posted in April 2014

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

Kits are packaged with the incorrect catheter. The kits contain a 40cm catheter and should contain a 50cm catheter.

FDA root cause category: Labeling mix-ups

What the company is doing

A recall notification letter, dated March 24, 2014 was sent to end users. " Urgent Medical Device Recall Notification "

Recall details

Recall number
Z-1494-2014
Recall class
Class II
Status
Terminated
Initiated by the company
Mar 24, 2014
Posted by the FDA
Apr 24, 2014
Recalling firm
Arrow International Inc
Quantity
789
Product code
LJS
FDA submissions
K121941
Distribution
Nationwide Distribution- Including the states of Az, Tn, Fl, Ga, Ca

Product description

Arrow Pressure Injectable PICC Powered by Arrow VPS Stylet Catalogue number CDC-35052-VPS, peripherally inserted central catheter.

Code information (models, lots, serial numbers)

lot #23F14A0375

Other devices under the same FDA submission

4 devices cleared under K121941 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.

Sources and updates

How recalls are matched to devices · Editorial policy · Report an error on this page