FDA-Device2015-10-21Class II
4FR Single Lumen Pressure Injectable PICC; intravascular therapeutic catheter, for long-term use greater than 30 days.
Arrow International Inc
Hazard
Labeling inaccuracy in the Instructions for Use (IFU) and Patient Card. The IFU and Patient Card with these products state the PICC can withstand up to ten (10) pressure injections, however, the PICC has only been tested to withstand five (5) pressure injections.
Sold states
Worldwide distribution. US Nationwide, Australia, Canada, and New Zealand.
Affected count
31590
Manufactured in
2400 Bernville Rd, N/A, Reading, PA, United States
Products
4FR Single Lumen Pressure Injectable PICC; intravascular therapeutic catheter, for long-term use greater than 30 days.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0127-2016Don't want to check this manually?
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