Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

CHS Custom Convenience Kit- PENROSE DRAIN (.75" X 18") Product Number:D8-9425B

FDA Recall Z-0260-2019 · Posted None

Recalling FirmCustom Healthcare Systems, Inc.
Recall StatusTerminated
Product CodeLRO
Date Initiated2018-08-13
Date Terminated2022-08-01
Product Quantity24 units

Reason for Recall

Convenience kits were sealed in immediate Tyvek pouches using incorrect specifications compromising product sterility

Firm Action

Custom Healthcare Systems (CHS) initiated recall by phone, email and by certified mail on 8/13/18 and carried out to the end user. Custom Healthcare Systems Inc. notified the customers, they were informed to contact their account to receive the product. Product to be returned and credited.

Root Cause

Packaging

Distribution Pattern

Connecticut, Georgia, Kentucky, North Carolina, Virginia, Maryland, Oklahoma, Illinois, South Carolina,

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

↑