Arrow-Flex(R) Percutaneous Sheath Introducer Kit with recall: Sterility Concern
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.…
Why was Arrow-Flex(R) Percutaneous Sheath Introducer Kit with 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: 13F17A0258 13F17D0075 13F17G0275 13F17L0615
- Product
- 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.…
- 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)