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Arrow IPNB00826

by Teleflex Incorporated

Arrow IPNB00826 (WJ-05401) is a Class II device made by Teleflex Incorporated, cleared under FDA 510(k) K140110 on 27 Mar 2015 and listed in FDA GUDID since 26 Oct 2026 (UDI-DI 10801902228267), active as of 9 Nov 2026.

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

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

3 ongoing

Recall on shared 510(k) K140110; other models may be affected

Documents

510(k) K140110

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 9 Nov 2026.

Regulatory status

as of registry sync 9 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10801902228267 UDI-DI Date26 Oct 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK140110 Date27 Mar 2015DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K140110 decided 27 Mar 2015 Active
  • FDA GUDID UDI-DI 10801902228267 listed 26 Oct 2026 Listed

Recalls

9 recalls · 3 ongoing · FDA

    • Ongoing Z-2371-2026 FDA Class I initiated 21 Apr 2026 on shared 510(k) K140110

    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.

    • Ongoing Z-1913-2026 FDA Class II initiated 11 Mar 2026 on shared 510(k) K140110

    Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured

    • Ongoing Z-2288-2020 FDA Class II initiated 8 May 2020 on shared 510(k) K140110

    Nine complaints reported that the rotatable collar on the filter had detached, causing a leak.

  • 3 recalls, same reason

    • Terminated Z-1174-2020 FDA Class II initiated 15 Jan 2020 on shared 510(k) K140110
    • Terminated Z-1177-2020 FDA Class II initiated 15 Jan 2020 on shared 510(k) K140110
    • Terminated Z-1172-2020 FDA Class II initiated 15 Jan 2020 on shared 510(k) K140110

    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.

  • 3 recalls, same reason

    • Terminated Z-1238-2020 FDA Class II initiated 20 Dec 2019 on shared 510(k) K140110
    • Terminated Z-1236-2020 FDA Class II initiated 20 Dec 2019 on shared 510(k) K140110
    • Terminated Z-1237-2020 FDA Class II initiated 20 Dec 2019 on shared 510(k) K140110

    Product lidstock contains the incorrect expiration date for the product

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

Timeline

11 dated events

  1. Recall initiated FDA recalls Z-1238-2020
  2. Recall initiated FDA recalls Z-1236-2020
  3. Recall initiated FDA recalls Z-1237-2020
  4. Recall initiated FDA recalls Z-1174-2020
  5. Recall initiated FDA recalls Z-1177-2020
  6. Recall initiated FDA recalls Z-1172-2020
  7. Recall initiated FDA recalls Z-2288-2020
  8. Recall initiated FDA recalls Z-1913-2026
  9. Recall initiated FDA recalls Z-2371-2026
  10. Listed FDA GUDID 10801902228267

1 earlier event are in the sections above.

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
IPNB00826, WJ-05401
Primary DI / UDI-DI
10801902228267
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 Unsafe

Related devices

Cleared under the same submission (K140110)

and 8 more cleared under K140110

Other devices from Teleflex Incorporated

  • Arrow IPNB00820 Open recall

    Class II

  • Arrow IPNB00822 Open recall

    Class II

  • Arrow IPNB00827 Open recall

    Class II

  • Arrow IPNB00823 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 (8, all answered No)