MAC(TM) Two-Lumen Central Venous Access Kit with ARROWg+ard Blue(R) Access Device, Integral Hemostasis Valve and Sharps Safety Features for use with 7.5 - 8 Fr. Catheters; Product Code: ASK-21242-NYP and ASK-21242-PR
Reported: June 6, 2018 Initiated: April 11, 2018 #Z-1983-2018
Product Description
MAC(TM) Two-Lumen Central Venous Access Kit with ARROWg+ard Blue(R) Access Device, Integral Hemostasis Valve and Sharps Safety Features for use with 7.5 - 8 Fr. Catheters; Product Code: ASK-21242-NYP and ASK-21242-PR
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? ▼
MAC(TM) Two-Lumen Central Venous Access Kit with ARROWg+ard Blue(R) Access Device, Integral Hemostasis Valve and Sharps Safety Features for use with 7.5 - 8 Fr. Catheters; Product Code: ASK-21242-NYP and ASK-21242-PR. 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-1983-2018.
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