PlainRecalls
FDA Devices Moderate Class II Terminated

Arrow-Johans" ECG Adapter for Right Atrial Electrocadiography (RAECG); Product Code: EG-04900

Reported: June 6, 2018 Initiated: April 11, 2018 #Z-2014-2018

Product Description

Arrow-Johans" ECG Adapter for Right Atrial Electrocadiography (RAECG); Product Code: EG-04900

Reason for Recall

Product sterility may be compromised due to unsealed packaging.

Details

Recalling Firm
Arrow International Inc
Units Affected
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
Location
Reading, PA

Frequently Asked Questions

What product was recalled?
Arrow-Johans" ECG Adapter for Right Atrial Electrocadiography (RAECG); Product Code: EG-04900. Recalled by Arrow International Inc. Units affected: 416,055 total products.
Why was this product recalled?
Product sterility may be compromised due to unsealed packaging.
Which agency issued this recall?
This recall was issued by the FDA Devices on June 6, 2018. Severity: Moderate. Recall number: Z-2014-2018.