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CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUS

by Arrow International, Inc. (Subsidiary of Teleflex, Inc.)

510(k) K153487

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK153487 Date4 Feb 2016ClearedStatusActive

Recalls

8 recalls · 1 ongoing · FDA

    • Ongoing Z-0001-2024 FDA Class I 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.

  • 3 recalls, same reason

    • Terminated Z-1810-2019 FDA Class II initiated 23 Apr 2019
    • Terminated Z-1808-2019 FDA Class II initiated 23 Apr 2019
    • Terminated Z-1807-2019 FDA Class II initiated 23 Apr 2019

    Lidstock states the incorrect expiration date for the product

  • 2 recalls, same reason

    • Terminated Z-1365-2019 FDA Class II initiated 13 Dec 2018
    • Terminated Z-1366-2019 FDA Class II initiated 13 Dec 2018

    Kits labeled as containing a 40 cm PICC may contain a 50 cm PICC, and kits labeled as containing a 50 cm PICC may contain a 40 cm PICC

  • 2 recalls, same reason

    • Terminated Z-3200-2018 FDA Class II initiated 17 Jul 2018
    • Terminated Z-3199-2018 FDA Class II initiated 17 Jul 2018

    The products may contain the incorrect catheter. Kits that should contain a 4.5 Fr single-lumen catheter may contain a 5.5 Fr double-lumen catheter. Kits that should contain a 5.5 Fr double-lumen catheter may contain a 4.5 Fr single-lumen catheter. This issue may cause a delay in treatment while a replacement catheter is obtained.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
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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