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Arrow IPN920677

by Teleflex Incorporated

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

1 ongoing

Recall on shared 510(k) K964142; other models may be affected

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 Number10801902196665 UDI-DI Date28 Jul 2026ListedStatusListed GUDID: in commercial distribution

Recalls

3 recalls · 1 ongoing · FDA

    • Ongoing Z-3079-2017 FDA Class II initiated 1 Jun 2017 on shared 510(k) K964142

    The sleeve seam of the breathable material was found to have inconsistent sealing, which has the potential to allow fluid to flow pass through the protective seam.

  • 2 recalls, same reason

    • Terminated Z-2010-2018 FDA Class II initiated 11 Apr 2018
    • Terminated Z-1963-2018 FDA Class II initiated 11 Apr 2018

    Product sterility may be compromised due to unsealed packaging.

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  • Withdrawn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 — GUDID listing Listed

Specification

GUDID

Trade Name
Arrow
Generic Name
Patient surgical drape, single-use
Model / Ref / Catalog
IPN920677, CD-00001
Primary DI / UDI-DI
10801902196665
510(k) Number
FDA Product Code
KKX
GMDN Term
Patient surgical drape, single-use
Device Class
Class II
Regulation Number
878.4370
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K964142)

Other devices from Teleflex Incorporated

See all devices from Teleflex Incorporated →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Convenience Kit
  • Combination Product
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (6)

  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No