FDA-Device2018-04-18Class II
PDS Plus Antibacterial (Polydioxanone) Suture Size 1 PDS PLUS Violet 27 Single Armed OS-4 Needle
Ethicon, Inc.
Hazard
Three (3) lots were distributed with the incorrect expiry date on the label. The lots were labeled with an expiry date of five (5) years from date of manufacture instead of the correct expiry date of two (2) years from date of manufacture.
Sold states
Distribution US Nationwide, Canada, India, and Colombia.
Affected count
72
Manufactured in
Us Highway 22 West, Somerville, NJ, United States
Products
PDS Plus Antibacterial (Polydioxanone) Suture Size 1 PDS PLUS Violet 27 Single Armed OS-4 Needle
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1339-2018Don't want to check this manually?
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