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Arterial Line Catheterization Kit with Sharps Safety… recallZ-2740-2016 · Arrow International Inc · initiated Aug 8, 2016

Class II Terminated All recalls posted in September 2016

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

Shipping carton labeling error.

FDA root cause category: Process control

What the company is doing

Teleflex sent an Urgent Medical Device Recall Notification letter dated August 23, 2016, via FED-Ex 2 Day Air. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately discontinue use and quarantine all affected products. Instructions for the products return were provided in the firm's recall notification letter. Customers were asked to complete the enclosed Acknowledgement Form and fax it to 1-855-419-8507, Attn: Customer Service or email it to [email protected]. Customers with questions were instructed to call 1-866-246-6990.

Recall details

Recall number
Z-2740-2016
Recall class
Class II
Status
Terminated
Initiated by the company
Aug 8, 2016
Posted by the FDA
Sep 7, 2016
Recalling firm
Arrow International Inc
Quantity
690 kits
Product code
DQX
FDA submissions
K810675
Distribution
Nationwide Distribution to OH, IN, TN, NC, and KY.

Product description

Arterial Line Catheterization Kit with Sharps Safety Features Permits access to the peripheral arterial circulation or to other small vessels.

Code information (models, lots, serial numbers)

Device Listing # D025180

Other devices under the same FDA submission

117 devices cleared under K810675 — 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 74986).

Sources and updates

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