Custom Healthcare Systems, Inc recall — FDA Z-0863-2020
A component (1961 TELFA PAD 2 X 3) contains LATEX and was used in the Medical Convenience Kit(PAK-19244). Case label and device label for product did NOT show that the Medical Convenience…
Overview of recall records associated with Custom Healthcare Systems, Inc., including dates, categories and classifications where available.
Classification mix: Class II: 5.
A component (1961 TELFA PAD 2 X 3) contains LATEX and was used in the Medical Convenience Kit(PAK-19244). Case label and device label for product did NOT show that the Medical Convenience…
Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility
This page summarizes recall records in which the official source identifies Custom Healthcare Systems, 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.