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Multi Lumen Central Venous Catheterization Kit with Blue… recallZ-0652-2018 · Arrow International Inc · initiated Oct 17, 2017

Class II Terminated All recalls posted in February 2018

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

These finished good kits may contain the incorrect Springwire Guide (SWG).

FDA root cause category: Process control

What the company is doing

On October 17, 2017 an Urgent Medical Device recall letter from Arrow International was issued to customers requesting that customers review their inventory for product, which should immediately be discontinued and quarantined. The products are then to be returned to the firm. Questions or concerns can be directed to: Customer Service at 18662466990.

Recall details

Recall number
Z-0652-2018
Recall class
Class II
Status
Terminated
Initiated by the company
Oct 17, 2017
Posted by the FDA
Feb 20, 2018
Recalling firm
Arrow International Inc
Quantity
5,926 total
Product code
DQY
FDA submissions
K862056
Distribution
Distribution US Nationwide

Product description

Multi Lumen Central Venous Catheterization Kit with Blue FlexTip Catheter, Sharps Safety Features, and Maximal Barrier Precautions Features; Product Code: ASK-12703-WMC1; Exp. Dates Feb 2018 - Nov 2018

Code information (models, lots, serial numbers)

Lot number: 23F17C0757

Other devices under the same FDA submission

132 devices cleared under K862056 — 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 79197).

Sources and updates

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