CooperSurgical Colpo-Pneumo Occluder, Part CPO-6 recall — FDA Z-0098-2019
The seal of the sterile pouch may be compromised, thereby increasing the risk of infection.
Overview of recall records associated with CooperSurgical, Inc., including dates, categories and classifications where available.
Classification mix: Class II: 47, Class III: 5, Class I: 3.
The seal of the sterile pouch may be compromised, thereby increasing the risk of infection.
There is a possibility that the seal of the sterile pouch may be compromised, thereby increasing the risk of infection.
Products have been packaged with the wrong Trocar length type.
The 2MHZ prove was incorrectlhttp://cts.fda.gov/division-tracking/images/trash.pngy labeled as a 3MHZ probe
The current secondary packaging, a box, incorrectly states that the product is latex free. The product is made with 100% latex. The label on the package that contains the product and the…
Products contain international package insert and not the correct USA package insert
Products contain international package insert and not the correct USA package insert
This page summarizes recall records in which the official source identifies CooperSurgical, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.