Data Foundry

Medical device recalls 2023

Presource Fistulogram Pack — Class II medical device recall Z-0092-2024

Ongoing recall by Cardinal Health 200, LLC, reported 2023-10-18, distributed nationwide. Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits).

Recall numberZ-0092-2024
Product typeMedical device
ClassificationClass II
StatusOngoing
Voluntary or mandatedVoluntary
Recalling firmCardinal Health 200, LLC, Waukegan, IL, United States
Recall initiated2023-08-16
Classified2023-10-10
Reported by FDA2023-10-18
DistributedNationwide (US)
Countries outside the USCA
Quantity13,351 packages
UPC / GTIN / UDI-DI10888439920840
Lot numbers23520
Expiration dates2025-02-01

Product

Presource Fistulogram Pack, Cat. SANOCFGHHA, Hartford Hospital, Sterile.

Reason for recall

Packs contain recalled components (equipment drapes, table cover, and surgical room turnover (SRT) kits).

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0092-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.