Skip to content

Arrow IPN045711

by Teleflex Incorporated United States GUDID

Product code BSO

Regulatory status

as of 24 Oct 2026

Recall ongoing. 3 ongoing FDA recalls. See recalls

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00801902059246 UDI-DIDate16 Sep 2016ListedStatusIn 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

    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

    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

    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
    • Terminated Z-1177-2020 FDA Class II initiated 15 Jan 2020
    • Terminated Z-1172-2020 FDA Class II initiated 15 Jan 2020

    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
    • Terminated Z-1236-2020 FDA Class II initiated 20 Dec 2019
    • Terminated Z-1237-2020 FDA Class II initiated 20 Dec 2019

    Product lidstock contains the incorrect expiration date for the product

Specification

GUDID · synced 22 Oct 2026

Trade Name
Arrow
Generic Name
Epidural anaesthesia set, medicated
Model / Ref / Catalog
IPN045711, ASK-05503-SPH
Primary DI / UDI-DI
00801902059246
510(k) Number
FDA Product Code
BSO
GMDN Term
Epidural anaesthesia set, medicated
Device Class
Class II
Regulation Number
868.5120
Commercial Distribution
In Commercial Distribution
MRI Safety
MR Unsafe
Size
Length — 90 Centimeter

Related devices

Category: Epidural anaesthesia set, medicated

Cleared under the same submission (K140110)

Show all (12)

Other devices from Teleflex Incorporated

See all devices from Teleflex Incorporated →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Single Use
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date
Other properties (8)
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No

Sources (1)

  • FDA UDI f20b98bb-92d9-44b1-a7ba-c3ffeab369f1 38 fields · synced 22 Oct 2026