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Arrow Nerve Block Component, Product Code: AB-18040-N:… recallZ-0573-2015 · Arrow International Inc · initiated Nov 10, 2014

Class II Terminated All recalls posted in December 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

Arrow is recalling certain lots of the Continuous Nerve Block Component, Product Code: AB-18040-N, due to a labeling inconsistency. The product lidstock incorrectly identifies the needle in the finished good as 17Ga rather than the correct 18Ga. The product included in the package is the correct 18Ga size. No injuries or illnesses have been reported.

FDA root cause category: Labeling False and Misleading

What the company is doing

An urgent medical device recall notification, dated November 11, 2014, was sent to consignees which identified the product, problem, and action to be taken. Customers with affected stock were asked to immediately discontinue use and quarantine any products with the catalog and lot number. To return product, the Recall Acknowledgement Form should be completed and faxed to 1-855-419-8507 Attn: Customer Service or email it to [email protected]. A customer service representative will be in contact to provide instructions for the return of product. All customers were asked to complete the Recall Acknowledgment Form and fax it to 1-855-419-8507, Attn: Customer Service or email it to [email protected].

Recall details

Recall number
Z-0573-2015
Recall class
Class II
Status
Terminated
Initiated by the company
Nov 10, 2014
Posted by the FDA
Dec 12, 2014
Recalling firm
Arrow International Inc
Quantity
786
Product code
CAZ
FDA submissions
K121403
Distribution
US Nationwide Distribution.

Product description

Arrow Nerve Block Component, Product Code: AB-18040-N: Permits placement of catheters next to nerves and nerve plexuses for continuous nerve block anesthesia or analgesia techniques for periods not exceeding 72 hours.

Code information (models, lots, serial numbers)

Product Number: AB-18040-N;  Lot Number:  RF2096425,  RF2010131,  RF1057898,  RF0074365,  RF0035689

Other devices under the same FDA submission

5 devices cleared under K121403 — 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

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