FDA-Device2023-02-15Class II
Sterile Procedural Trays, labeled as the following: a. CARDIAC CATH PACK-LF; b. ANGIOGRAPHY-NS-LF; c. EP BASIC SET UP PACK; d. IMPLANT PACK-LF; e. PORT PACEMAKER INSERTION PACK; f. OPEN HEART PACK; g. LAP BASIN TRAY; h. ANGIO ACCESS; i. ANGIO
MEDLINE INDUSTRIES, LP - Northfield
Hazard
Sterile blades within sterile kits have the potential for the blade to puncture the outer foil layer of the sterile packaging.
Sold states
Worldwide distribution - US Nationwide and the countries of Canada, Japan, Mexico, Panama, Turks & Caicos, United Arab Emirates.
Affected count
314 cases (719 units)
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
Sterile Procedural Trays, labeled as the following: a. CARDIAC CATH PACK-LF; b. ANGIOGRAPHY-NS-LF; c. EP BASIC SET UP PACK; d. IMPLANT PACK-LF; e. PORT PACEMAKER INSERTION PACK; f. OPEN HEART PACK; g. LAP BASIN TRAY; h. ANGIO ACCESS; i. ANGIO
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1066-2023Don't want to check this manually?
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