Halyard 88291

by O&M Halyard Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

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

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number10680651882919 UDI-DI	Date15 Dec 2015Listed	StatusListed GUDID: in commercial distribution

Recalls

2 recalls · 2 ongoing · FDA

- Ongoing Z-2520-2025 FDA Class II initiated 17 Jul 2025
Surgical drape packs may have open seals, which may compromise the sterility of the product.
- Ongoing Z-0983-2025 FDA Class II initiated 26 Nov 2024
Elevated residues of anti-block/slip additive used in manufacturing found within sterile packaging.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: Halyard
Generic Name: General surgical procedure kit, non-medicated, single-use
Model / Reference: 88291

Primary DI / UDI-DI: 10680651882919
510(k) Number: K083234
FDA Product Code: KKX
GMDN Term: General surgical procedure kit, non-medicated, single-use

Device Class: Class II
Regulation Number: 878.4370
GUDID distribution status: In Commercial Distribution

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Properties

Sterile
Single Use
Lot / Batch Number
Expiration Date

Other properties (10)

Implantable: No
Contains Latex: No
Prescription Use: No
Over-the-Counter: No
Convenience Kit: No
Combination Product: No
HCT/P: No
Premarket Exempt: No
Serial Number: No
Manufacturing Date: No