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Arrow IPN920595

by Teleflex Incorporated

Ref AS-05500

Arrow IPN920595 (AS-05500) is a device classified as Class IIa in the EU and Class II in the US made by Teleflex Incorporated, registered in EUDAMED on 19 May 2026 (Basic UDI-DI 08019020000000000000158KU), cleared under FDA 510(k) K103658 on 16 May 2012 and listed in FDA GUDID since 2 May 2024 (UDI-DI 10801902195859), active as of 23 Oct 2026. 3 FDA recalls are linked to it.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

1 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K103658

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number08019020000000000000158KU Basic UDI-DI 10801902195859UDI-DIDate19 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10801902195859 UDI-DI Date2 May 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK103658 Date16 May 2012DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 08019020000000000000158KU registered 19 May 2026 Active
  • FDA 510(k) K103658 decided 16 May 2012 Active
  • FDA GUDID UDI-DI 10801902195859 listed 2 May 2024 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

7 dated events

  1. Cleared FDA 510(k) K103658
  2. Recall initiated FDA recalls Z-2462-2015
  3. Recall initiated FDA recalls Z-1962-2018
  4. Recall initiated FDA recalls Z-1179-2020
  5. Listed FDA GUDID 10801902195859
  6. Recall initiated FDA recalls Z-2364-2026
  7. Registered EUDAMED 08019020000000000000158KU

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
SnapLock(TM) Catheter/Syringe Adapter EUDAMED
Arrow GUDID
Generic name
Luer/epidural catheter linear connector
Device name
SnapLock Adapter
Model / Ref / Catalog
AS-05500, IPN920595
Primary DI / UDI-DI
10801902195859
Basic UDI-DI
08019020000000000000158KU
510(k) Number
FDA product code
CAZ
EMDN code
A070103 Infusion tubing adapters and connectors
GMDN term
Luer/epidural catheter linear connector
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
868.5140
EU registration type
Standard device
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution
MRI safety
MR Safe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
AS-05500
GUDID
IPN920595
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Luer/epidural catheter linear connector

Cleared under the same submission (K103658)

and 8 more cleared under K103658

Similar devices in this category

Other devices filed under INFUSION TUBING ADAPTERS AND CONNECTORS.

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
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (18, all answered No)