FDA-Device2023-02-15Class II
Sterile Procedural Trays, labeled as the following: a. BREAST BIOPSY PACK-LF b. BREAST BIOPSY PACK c. LAPAROTOMY PACK d. BREAST PACK e. SOFT TISSUE PACK f. HEMORRHOID PACK g. RECTAL h. BREAST i. BREAST
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
200 cases (858 units)
Manufactured in
3 Lakes Dr, Northfield, IL, United States
Products
Sterile Procedural Trays, labeled as the following: a. BREAST BIOPSY PACK-LF b. BREAST BIOPSY PACK c. LAPAROTOMY PACK d. BREAST PACK e. SOFT TISSUE PACK f. HEMORRHOID PACK g. RECTAL h. BREAST i. BREAST
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1069-2023Don't want to check this manually?
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