Arrow Pressure Injectable Picc

• • Terminated Z-1255-2020 FDA Class II ·initiated 20 Dec 2019

  Product lidstock contains the incorrect expiration date for the product

• • Terminated Z-2020-2018 FDA Class II ·initiated 11 Apr 2018

  Product sterility may be compromised due to unsealed packaging.

• • Terminated Z-1325-2018 FDA Class II ·initiated 22 Dec 2017

  Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.

• • Terminated Z-2338-2017 FDA Class II ·initiated 9 May 2017

  The Arrow Pressure Injectable PICC is intended for short-term or long-term peripheral access to the central venous system for intravenous therapy and blood sampling.

• 4 recalls, same reason

  • Terminated Z-2772-2016 FDA Class II ·initiated 17 Feb 2016
  • Terminated Z-2774-2016 FDA Class II ·initiated 17 Feb 2016
  • Terminated Z-2771-2016 FDA Class II ·initiated 17 Feb 2016
  • Terminated Z-2773-2016 FDA Class II ·initiated 17 Feb 2016

  Notification of component molding abnormality by supplier used to package certain Arrow Select Kit (ASK) products.

• • Terminated Z-0127-2016 FDA Class II ·initiated 18 Sep 2015

  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.

• • Terminated Z-2462-2015 FDA Class II ·initiated 30 Jul 2015

  the catheter peel-away component hub tabs may prematurely detach. One injury reported.

• • Terminated Z-1682-2010 FDA Unclassified (pre-2012) ·initiated 29 Mar 2010

  Tight fit in sheath. Arrow has received complaints of the PICC catheter fitting too tightly in the "kit supplied" peelable sheath. In some cases, clinicians have been unable to insert the catheter through the peelable sheath during the insertion procedure. If the catheter will not pass through the sheath, the clinician is required to place a guide wire back into the sheath, remove the sheath, a

510(k) Number

K061289 ↗

FDA Product Code

LJS

Device Class

Class II

Regulation

21 CFR Part 880.5970

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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  FDA 510(k) K130876 Active Cleared 26 Apr 2013

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  FDA 510(k) K071538 Active Cleared 30 Aug 2007

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  Class II

  FDA 510(k) K190117 Active Cleared 13 Jun 2019

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