Skip to content

Arrow IPN036694

by Teleflex Incorporated

Arrow IPN036694 (ASK-00376-SU) is a Class I device made by Teleflex Incorporated, cleared under FDA 510(k) K874063 on 4 Dec 1987 and listed in FDA GUDID since 16 Sep 2016 (UDI-DI 10801902120189), active as of 23 Oct 2026. 3 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

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

510(k) K874063

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10801902120189 UDI-DI Date16 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESD from GUDID Substantially Equivalent — Deferred · Traditional NumberK874063 Date4 Dec 1987DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K874063 decided 4 Dec 1987 Active
  • FDA GUDID UDI-DI 10801902120189 listed 16 Sep 2016 Listed

Recalls

3 recalls · 1 ongoing · FDA

    • Ongoing Z-2386-2026 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.

    • Terminated Z-1965-2018 FDA Class II initiated 11 Apr 2018

    Product sterility may be compromised due to unsealed packaging.

    • Terminated Z-1297-2018 FDA Class II initiated 24 Oct 2017

    Product packaging may not be completely sealed.

Timeline

5 dated events

  1. Cleared FDA 510(k) K874063
  2. Listed FDA GUDID 10801902120189
  3. Recall initiated FDA recalls Z-1297-2018
  4. Recall initiated FDA recalls Z-1965-2018
  5. Recall initiated FDA recalls Z-2386-2026

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Arrow
Generic name
Pleural/peritoneal drainage catheterization kit, non-medicated
Model / Ref / Catalog
IPN036694, ASK-00376-SU
Primary DI / UDI-DI
10801902120189
510(k) Number
FDA product code
KDD
GMDN term
Pleural/peritoneal drainage catheterization kit, non-medicated
Device class
Class I
Regulation number
878.4800
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Related devices

Category: Pleural/peritoneal drainage catheterization kit

Cleared under the same submission (K874063)

and 7 more cleared under K874063

Similar devices in this category

Other devices filed under Pleural/peritoneal drainage catheterization kit.

Other devices from Teleflex Incorporated

  • Arrow IPNB00820 Open recall

    Class II

  • Arrow IPNB00826 Open recall

    Class II

  • Arrow IPNB00822 Open recall

    Class II

  • Arrow IPNB00827 Open recall

    Class II

See all devices from Teleflex Incorporated →

Properties

  • Supplied sterile
  • Single use
  • Implantable
  • Contains latex
  • Prescription use
  • Convenience kit
  • Combination product
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (5, all answered No)