FDAClass IIJune 6, 2018

7Fr. Catheter Clamp with Fastener recall: Sterility Concern

7Fr. Catheter Clamp with Fastener; Product Code: CC-00007

Why was 7Fr. Catheter Clamp with Fastener recalled?

Product sterility may be compromised due to unsealed packaging.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot Numbers: 13F17B0257 13F17D0260 13F17E0342 13F17F0076 13F17F0795 13F17J0271

Product
7Fr. Catheter Clamp with Fastener; Product Code: CC-00007
Recalling firm
Arrow International Inc
Quantity
416,055 total products
Distribution
US Nationwide, AUSTRALIA, AUSTRIA, BELGIUM, CANADA, CZECH REPUBLIC, DENMARK, ECUADOR, FRANCE, GERMANY, GREECE, HONG KONG, INDONESIA, IRELAND, ITALY, JAPAN, KOREA, NETHERLANDS, NEW ZEALAND, PANAMA, PHILIPPINES, POLAND, PUERTO RICO, ROMANIA, SAUDI ARABIA, SINGAPORE, SLOVENIA, SOUTH AFRICA, SPAIN, SWEDEN, SWITZERLAND, THAILAND, TRINIDAD AND TOBAGO, UNITED KINGDOM
Recall date
June 6, 2018
Classification
Class II
Status
Terminated
Agency
FDA (device)
Open FDA enforcement record Latest recalls