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.

Open, Classified

Sterile Procedural Trays, labeled as the following: a. ST. ANNE'S MAJOR BASIN SET UP b. SINGLE BASIN SET c. DOUBLE BASIN SET d. LAPAROTOMY BASIN e. ORTHOPEDIC CUSTOM BASIN SET f. OISC BASIN TRAY g. BASIN PACK h. BASIN SET i. SURGI START PACK j. PK, GEN-SET UP - MIDWEST k. SINGLE BASIN PACK-LF l. AGHM MINOR SINGLE PACK m. MINOR PACK n. SINGLE BASIN PACK o. MAJOR BASIN PACK p. BASIC SET UP-LF q. BASIC SET-UP-LF r. BASIN PACK s. MINOR BASIN t. AMC MAJOR BASIN u. AMC MAJOR BASIN

FDA Recall Z-1078-2023 · Posted 2023-02-06

Recalling FirmMEDLINE INDUSTRIES, LP - Northfield
Recall StatusOpen, Classified
Product CodeKDD
Date Initiated2022-11-17
Product Quantity2.542 cases (6,739 units)

Reason for Recall

Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.

Firm Action

Medline Industries, LP notified consignees via email and first-class mail on 11/15/2022. Consignees were instructed to check stock for affected product and immediately quarantine. For any affected units, customers were instructed to over-label the sterile kits with a warning label indicating "Warning To Avoid Injury, Please Handle Blades with Care." No product is to be returned. Customers were also instructed to complete and return the response form and notify customers if further distributed.

Root Cause

Device Design

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.

Official Source

View FDA Recall →

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

↑