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Arrow IPN927039

by Teleflex Incorporated

Arrow IPN927039 (ASK-32041-LMDTG) is a peripheral intravenous catheterization kit (FDA Class II; FDA product code PND, Midline catheter) made by Teleflex Incorporated, cleared under FDA 510(k) K213855 on 2 Sep 2022 and listed in FDA GUDID since 1 Aug 2024 (UDI-DI 10801902213065), active as of 23 Oct 2026. One FDA recall is 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) K213855

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 Number10801902213065 UDI-DI Date1 Aug 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK213855 Date2 Sep 2022DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K213855 decided 2 Sep 2022 Active
  • FDA GUDID UDI-DI 10801902213065 listed 1 Aug 2024 Listed

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-2387-2026 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.

Timeline

3 dated events

  1. Cleared FDA 510(k) K213855
  2. Listed FDA GUDID 10801902213065
  3. Recall initiated FDA recalls Z-2387-2026

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  • Withdrawn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
Peripheral intravenous catheterization kit, non-sensing
Model / Ref / Catalog
IPN927039, ASK-32041-LMDTG
Primary DI / UDI-DI
10801902213065
510(k) Number
FDA product code
PND
GMDN term
Peripheral intravenous catheterization kit, non-sensing
Device class
Class II
Regulation number
880.5200
GUDID distribution status
In Commercial Distribution
MRI safety
MR Safe

Related devices

Category: Peripheral intravenous catheterization kit, non-sensing

Cleared under the same submission (K213855)

Similar devices

Other devices filed under FDA product code PND (Midline catheter).

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)