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Arrow IPNB00823

by Teleflex Incorporated

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

Registry data, not yet checked by deviCERTS. Source GUDID, synced 9 Nov 2026. What this means

Regulatory status

as of registry sync 9 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10801902228243 UDI-DI Date26 Oct 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK140110 Date27 Mar 2015DecidedStatusActive

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.

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
IPNB00823, MP-17019-TK
Primary DI / UDI-DI
10801902228243
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)

Show all (12)

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

  • Arrow IPNB00828 Open recall

    Class II

  • Arrow IPNB00825

    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)

  • Sterilise before use: No
  • Implantable: No
  • Contains latex: No
  • Over-the-counter: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No