Data Foundry

Medical device recalls 2018

Spectrum Central Venous Catheter Tray Minocycline/Rifampin Antibiotic… — Class II medical device recall Z-0634-2018

Terminated recall by Cook Inc., reported 2018-02-21, distributed nationwide. Central venous catheters may not fit over guide wire potentially causing procedure delay.

Recall numberZ-0634-2018
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmCook Inc., Bloomington, IN, United States
Recall initiated2017-07-31
Classified2018-02-15
Reported by FDA2018-02-21
Terminated2019-05-08
DistributedNationwide (US)
Countries outside the USBE, ES, GB, IN, IT
Quantity304
Lot numbers7611811, 7625110, 7625111, 7689802, 7693203, 7713113, 7724842

Product

Spectrum Central Venous Catheter Tray Minocycline/Rifampin Antibiotic Impregnated, Catalog Identifiers: C-UTLMY-501J-ABRM-HC-FST and C-UTLMY-501J-ABRM-HC-IHI-FST Usage: The Spectrum Central Venous Catheter is used for the intravenous administration of nutrient fluids, chemotherapeutic agents, and other drugs for therapy, blood sampling, blood delivery, and venous pressure monitoring

Reason for recall

Central venous catheters may not fit over guide wire potentially causing procedure delay.

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-0634-2018. 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.