Arrow Two-Lumen Central Venous Catheterization Set with Blue FlexTip(R) ARROWgard Blue(R) Catheter Product Usage: The multiple-lumen catheter permits venous access to central circulation.
Reported: July 4, 2012 Initiated: May 3, 2012 #Z-1830-2012
Product Description
Arrow Two-Lumen Central Venous Catheterization Set with Blue FlexTip(R) ARROWgard Blue(R) Catheter Product Usage: The multiple-lumen catheter permits venous access to central circulation.
Reason for Recall
Lidstock of product does not contain chlorhexidine contraindication and contains wording "contains no medication" on the label. Product insert does reflect medicated status.
Details
- Recalling Firm
- Arrow International Inc
- Units Affected
- 634,912
- Distribution
- Worldwide Distribution - United States (nationwide) include the state of Texas. and the countries of: ARMENIA, AUSTRALIA, AUSTRIA, AZERBAIJAN, BAHRAIN, BELGIUM, CANADA, CHILE, COLOMBIA, COSTA RICA, CYPRUS, CZECH REPUBLIC, DENMARK, DOMINICAN REPUBLIC, ESTONIA, FINLAND, FRANCE, GEORGIA, GERMANY, GREECE, GUATEMALA, HUNGARY, INDIA, ITALY, IRELAND, KENYA, KUWAIT, KYRGYZSTAN, LATVIA, LEBANON, LITHUANIA, LUXEMBOURG, MONTENEGRO, NETHERLANDS, NEW ZEALAND, NORWAY, OMAN, POLAND, PORTUGAL, QATAR, R¿UNION, ROMANIA, RUSSIAN FEDERATION, SAUDI ARABIA, SERBIA, SINGAPORE, SLOVAKIA, SLOVENIA, SOUTH AFRICA, SPAIN, SWITZERLAND, TURKEY, UKRAINE, , UNITED ARAB EMIRATES and UNITED KINGDOM.
- Location
- Reading, PA
Frequently Asked Questions
What product was recalled? ▼
Arrow Two-Lumen Central Venous Catheterization Set with Blue FlexTip(R) ARROWgard Blue(R) Catheter Product Usage: The multiple-lumen catheter permits venous access to central circulation.. Recalled by Arrow International Inc. Units affected: 634,912.
Why was this product recalled? ▼
Lidstock of product does not contain chlorhexidine contraindication and contains wording "contains no medication" on the label. Product insert does reflect medicated status.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on July 4, 2012. Severity: Critical. Recall number: Z-1830-2012.
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