Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Microtek Franz Angiography Drape with Radiation Shield, Item # RBA202, and Microtek Angiography Drape with Radiation Shield and Pouches, Item # RBA203. Sterile EO. Microtek Medical, Inc., Columbus, MS 39702.

FDA Recall Z-2744-2016 · Posted None

Recalling FirmEcolab Inc
Recall StatusTerminated
Product CodeKKX
Date Initiated2016-07-14
Date Terminated2016-11-02
Product Quantity6750 eaches (675 cases)

Reason for Recall

Ecolab is recalling 2 models of Angiography Drapes with Radiation Shields because the sterile packaging may contain small holes in the film of the pouch.

Firm Action

Consignees were sent on 7/14/2016 an Ecolab "Urgent Medical Device Recall" letter dated July 14, 2016. The letter described the problem and the product involved in the recall. Advised consignees to immediately quarantine the product and to notify their customers. For questions contact Customer Service at 1-800-824-3027.

Root Cause

Packaging process control

Distribution Pattern

US: OH, NY, CA, MN.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑