Arrow-Flex(R) Percutaneous Sheath Introducer Kit with ARROWg+ard Blue(R) Sheath and Integral Hemostasis Valve/Side Port for use with 7.5 - 8 Fr. Catheters ; Product Codes: ASK-09903-UM
Reported: June 6, 2018 Initiated: April 11, 2018 #Z-1975-2018
Product Description
Arrow-Flex(R) Percutaneous Sheath Introducer Kit with ARROWg+ard Blue(R) Sheath and Integral Hemostasis Valve/Side Port for use with 7.5 - 8 Fr. Catheters ; Product Codes: ASK-09903-UM
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-Flex(R) Percutaneous Sheath Introducer Kit with ARROWg+ard Blue(R) Sheath and Integral Hemostasis Valve/Side Port for use with 7.5 - 8 Fr. Catheters ; Product Codes: ASK-09903-UM. 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-1975-2018.
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