Skip to content

Cg+ Arrow Jacc Powered by Arrow Vps Stylet

by Arrow International (Subsidiary of Teleflex Inc.)

510(k) K132133

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 NumberK132133 Date26 Sep 2013ClearedStatusActive

Recalls

9 recalls · 1 ongoing · FDA

    • Ongoing Z-2379-2026 FDA Class I initiated 21 Apr 2026

    Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality issues and limited reports of drug ineffectiveness, and if sterility of a water-based injectable product is compromised this could lead to serious or life-threatening injuries.

  • 6 recalls, same reason

    • Terminated Z-1815-2019 FDA Class II initiated 23 Apr 2019 on shared 510(k) K132133
    • Terminated Z-1817-2019 FDA Class II initiated 23 Apr 2019 on shared 510(k) K132133
    • Terminated Z-1812-2019 FDA Class II initiated 23 Apr 2019 on shared 510(k) K132133
    • Terminated Z-1806-2019 FDA Class II initiated 23 Apr 2019 on shared 510(k) K132133
    • Terminated Z-1816-2019 FDA Class II initiated 23 Apr 2019 on shared 510(k) K132133
    • Terminated Z-1814-2019 FDA Class II initiated 23 Apr 2019 on shared 510(k) K132133

    Lidstock states the incorrect expiration date for the product

    • Terminated Z-2015-2018 FDA Class II initiated 11 Apr 2018

    Product sterility may be compromised due to unsealed packaging.

    • Terminated Z-0207-2016 FDA Class II initiated 16 Oct 2015 on shared 510(k) K132133

    Possibility that the catheter peel-away component hub tabs may prematurely detach when the practitioner begins to peel apart the sheath body from the catheter. Although the issue does not pose a significant risk to the patient, it may cause a delay of treatment when placing the catheter.

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

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  • Withdrawn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
OBJ
Device Class
Class II
Regulation
21 CFR Part 870.1200
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Other devices from Arrow International, Inc. (Subsidiary of Teleflex, Inc.)

See all devices from Arrow International, Inc. (Subsidiary of Teleflex, Inc.) →