Sterile Procedural Trays, labeled as the following: a. BASIN SET-UP PACK b. LAP CHOLE CDS c. MAJOR CDS d. UROLOGY MINOR
FDA device recall Z-1079-2023 · posted 2023-02-06 · Open, Classified
Recall details
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Reason for recall
- Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
- Action taken
- 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
- Status
- Open, Classified
- Product code
- LRO
- Quantity affected
- 62,930 cases (215,456 units)
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.
- Date initiated
- 2022-11-17
- Date posted
- 2023-02-06
- Location
- Northfield, IL
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