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Arrow IPN030088

by Teleflex Incorporated 2 variants

Arrow IPN030088 (CS-15122-E) is a Class II device made by Teleflex Incorporated, cleared under FDA 510(k) K993933 on 14 Sep 2000 and listed in FDA GUDID since 2 Feb 2017 (UDI-DI 00801902001122), active as of 22 Oct 2026. 5 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) K993933

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00801902001122 UDI-DI Date2 Feb 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK993933 Date14 Sep 2000DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K993933 decided 14 Sep 2000 Active
  • FDA GUDID UDI-DI 00801902001122 listed 2 Feb 2017 Listed

Recalls

5 recalls · 1 ongoing · FDA

    • Ongoing Z-2373-2026 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-1336-2018 FDA Class II initiated 22 Dec 2017

    Certain lots of cardiovascular catheters may not be completely sealed and so sterility of the product cannot be guaranteed.

    • Terminated Z-0658-2018 FDA Class II initiated 17 Oct 2017

    These finished good kits may contain the incorrect Springwire Guide (SWG).

    • Terminated Z-2334-2017 FDA Class II initiated 9 May 2017

    Arrow International is recalling the affected product because the packaging may not be completely sealed, which may compromise sterility.

    • Terminated Z-0639-04 FDA Unclassified (pre-2012) initiated 18 Feb 2004

    catheter slips out of the suture wing during use.

Timeline

7 dated events

  1. Cleared FDA 510(k) K993933
  2. Recall initiated FDA recalls Z-0639-04
  3. Listed FDA GUDID 00801902001122
  4. Recall initiated FDA recalls Z-2334-2017
  5. Recall initiated FDA recalls Z-0658-2018
  6. Recall initiated FDA recalls Z-1336-2018
  7. Recall initiated FDA recalls Z-2373-2026

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
Double-lumen haemodialysis catheter, nonimplantable
Model / Ref / Catalog
IPN030088, CS-15122-E
Primary DI / UDI-DI
00801902001122
510(k) Number
FDA product code
MPB
GMDN term
Double-lumen haemodialysis catheter, nonimplantable
Device class
Class II
Regulation number
876.5540
GUDID distribution status
In Commercial Distribution
MRI safety
MR Conditional
Size
Length — 20 Centimeter
Catheter Gauge — 12 French

Related devices

Category: Double-lumen haemodialysis catheter, nonimplantable

Cleared under the same submission (K993933)

and 8 more cleared under K993933

Similar devices in this category

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
Other properties (9, all answered No)