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Arrow Csd-15242-Sp

by Teleflex Incorporated

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

3 ongoing

This device is named in the recall

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10801902154597 UDI-DI Date17 Apr 2026ListedStatusListed GUDID: in commercial distribution

Recalls

4 recalls · 3 ongoing · FDA

  • 3 recalls, same reason

    • Ongoing Z-2156-2026 FDA Class I initiated 10 Apr 2026
    • Ongoing Z-2159-2026 FDA Class I initiated 10 Apr 2026
    • Ongoing Z-2158-2026 FDA Class I initiated 10 Apr 2026

    16F dual-valved splittable sheath introducer, the subject of a supplier recall, was included in impacted hemodialysis kits & sets. Sheath introducer may not split as intended, and may result in withdrawal resistance, prolonged procedure time, pain, bleeding, hematoma, tissue injury, vessel wall injury.

    • Terminated Z-1007-2015 FDA Class II initiated 4 Feb 2013

    The tunneling sheath packaged within the kits can crack during placement. If the tunneling sheath cracks, it can cause a delay in treatment for the time it takes to retrieve a replacement kit.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Arrow
Generic Name
Double-lumen haemodialysis catheter, implantable
Model / Ref / Catalog
CSD-15242-SP
Primary DI / UDI-DI
10801902154597
510(k) Number
FDA Product Code
MSD
GMDN Term
Double-lumen haemodialysis catheter, implantable
Device Class
Class II
Regulation Number
876.5540
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Conditional
Size
Catheter Gauge — 15.0 French
Length — 19.0 Centimeter

Related devices

Cleared under the same submission (K111117)

Show all (12)

Other devices from Teleflex Incorporated

See all devices from Teleflex Incorporated →

Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Manufacturing Date

Other properties (7)

  • Contains Latex: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No