FDA-Device2012-09-19Class II
Bard Foley procedural trays packaged in breather bags. The product is packaged ten units in each shipper box, and are sold sterile for single use. Used to catheterize patients. The finished trays are sold in Tyvek breather bags.
C.R. Bard, Inc., Urological Division
Hazard
Incomplete seal on sterile packages of product.
Sold states
Nationwide distribution: USA
Affected count
56,694 units
Manufactured in
8195 Industrial Blvd Ne, N/A, Covington, GA, United States
Products
Bard Foley procedural trays packaged in breather bags. The product is packaged ten units in each shipper box, and are sold sterile for single use. Used to catheterize patients. The finished trays are sold in Tyvek breather bags.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2327-2012Don't want to check this manually?
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