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Arrow Ak-05503

by Teleflex Incorporated United States GUDID

Product code CAZ

Regulatory status

as of 24 Oct 2026

Recall ongoing on a related submission. 3 ongoing FDA recalls. See recalls

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10801902228045 UDI-DIDate9 Oct 2026ListedStatusIn distribution

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Listed
  • Not covered

United States — GUDID listing Listed

Recalls

9 recalls · 3 ongoing · FDA

    • Ongoing Z-2371-2026 FDA Class I initiated 21 Apr 2026 via K140110, on the same 510(k)

    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 via K140110, on the same 510(k)

    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 via K140110, on the same 510(k)

    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 via K140110, on the same 510(k)
    • Terminated Z-1177-2020 FDA Class II initiated 15 Jan 2020 via K140110, on the same 510(k)
    • Terminated Z-1172-2020 FDA Class II initiated 15 Jan 2020 via K140110, on the same 510(k)

    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 via K140110, on the same 510(k)
    • Terminated Z-1236-2020 FDA Class II initiated 20 Dec 2019 via K140110, on the same 510(k)
    • Terminated Z-1237-2020 FDA Class II initiated 20 Dec 2019 via K140110, on the same 510(k)

    Product lidstock contains the incorrect expiration date for the product

Recalls marked "via" name another device cleared under the same FDA submission as this one.

Specification

GUDID · synced 23 Oct 2026

Trade Name
Arrow
Generic Name
Epidural anaesthesia set, medicated
Model / Ref / Catalog
AK-05503
Primary DI / UDI-DI
10801902228045
510(k) Number
FDA Product Code
CAZ
GMDN Term
Epidural anaesthesia set, medicated
Device Class
Class II
Regulation Number
868.5140
Commercial Distribution
In Commercial Distribution
MRI Safety
MR Unsafe

Related devices

Cleared under the same submission (K140110)

Show all (12)

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Single Use
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date
Other properties (7)
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No

Sources (1)

  • FDA UDI b2923a5b-aa47-45ae-b3e7-ba63775019e7 36 fields · synced 23 Oct 2026