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Terminated

4FR Single Lumen Pressure Injectable PICC; intravascular therapeutic catheter, for long-term use greater than 30 days.

FDA Recall Z-0127-2016 · Posted 2015-10-15

Recalling FirmArrow International Inc
Recall StatusTerminated
Product CodeLJS
Date Initiated2015-09-18
Date Terminated2020-06-25
Product Quantity31590

Reason for Recall

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.

Firm Action

An urgent medical device notification, dated September 22, 2015, was sent to direct accounts to alert them about the issue, the potential risks, and provide instructions for returning the completed response form and affected devices.

Root Cause

Under Investigation by firm

Distribution Pattern

Worldwide distribution. US Nationwide, Australia, Canada, and New Zealand.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K073451PRESSURE INJECTABLE PICCArrow International, Inc. · 2008-01-15K061289ARROW PRESSURE INJECTABLE PICCArrow International, Inc. · 2006-08-24

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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