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Arrow International Inc recalls 4FR Single Lumen Pressure Injectable PICC; intravascular therapeutic catheter, for long-term use greater than 30 days.
Recalled October 21, 2015 · FDA recall Z-0127-2016 · Arrow International
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. · FDA Class II
Units
31590
Sold at
Worldwide distribution. US Nationwide, Australia, Canada, and New Zealand.
Description
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.
Product
4FR Single Lumen Pressure Injectable PICC; intravascular therapeutic catheter, for long-term use greater than 30 days.
Manufacturer(s)
Arrow International Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →