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Arrow IPN037393

by Teleflex Incorporated

Arrow IPN037393 (ASK-05502-SMC) is a Class II device made by Teleflex Incorporated, cleared under FDA 510(k) K103658 on 16 May 2012 and listed in FDA GUDID since 30 Sep 2016 (UDI-DI 10801902125016), 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) K103658

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 Number10801902125016 UDI-DI Date30 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK103658 Date16 May 2012DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K103658 decided 16 May 2012 Active
  • FDA GUDID UDI-DI 10801902125016 listed 30 Sep 2016 Listed

Recalls

4 recalls · 1 ongoing · FDA

    • Ongoing Z-2364-2026 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-1179-2020 FDA Class II initiated 15 Jan 2020

    There is the potential for various failures with the LOR (loss of resistance) syringes included in the kits resulting in dural puncture with some also requiring a blood patch.

    • Terminated Z-1962-2018 FDA Class II initiated 11 Apr 2018

    Product sterility may be compromised due to unsealed packaging.

    • Terminated Z-2462-2015 FDA Class II initiated 30 Jul 2015 on shared 510(k) K103658

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

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

Timeline

6 dated events

  1. Cleared FDA 510(k) K103658
  2. Recall initiated FDA recalls Z-2462-2015
  3. Listed FDA GUDID 10801902125016
  4. Recall initiated FDA recalls Z-1962-2018
  5. Recall initiated FDA recalls Z-1179-2020
  6. Recall initiated FDA recalls Z-2364-2026

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
Epidural anaesthesia set, medicated
Model / Ref / Catalog
IPN037393, ASK-05502-SMC
Primary DI / UDI-DI
10801902125016
510(k) Number
FDA product code
CAZ
GMDN term
Epidural anaesthesia set, medicated
Device class
Class II
Regulation number
868.5140
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional

Related devices

Category: Epidural anaesthesia set, medicated

Cleared under the same submission (K103658)

and 8 more cleared under K103658

Similar devices

Other devices filed under FDA product code CAZ (Anesthesia conduction 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
  • Prescription use
  • Convenience kit
  • Combination product
  • Lot / batch number
  • Expiration date
Other properties (8, all answered No)