Pressure Injectable Picc

• • Ongoing Z-2590-2023 FDA Class II ·initiated 10 Aug 2023

  This recall has been initiated due to reports that the product code and product name were incorrectly listed on the lidstock of affected kits.

• • 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-2489-2015 FDA Class II ·initiated 30 Jul 2015 ·on shared 510(k) K073451

  saline leakage from unsecured connections between the Touhy Borst adaptor and the hub of the catheter. No injuries reported.

• • Terminated Z-0066-2015 FDA Class II ·initiated 6 Aug 2014 ·on shared 510(k) K073451

  The component supplier recalled their 0.9% Sodium Chloride Injection USP BD Posiflush SF Saline Flush Syringe 10mL because some unit packages may exhibit open seals which impact package integrity and potentially product sterility.

• • 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

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

510(k) Number

K073451 ↗

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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