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

Presource PBDS, Kit, Common Diabetes. Kit includes a exerciser volumetric 5000 ML device, two items of cloth, skin prep 2% CHG, a packet of 4 chlorhexidine gluconate antiseptic cloths, and Gatorade pouches. Product Usage: The kit is provided to a patient pre-surgery, as part of the Enhanced Recovery After Surgery protocol. Items included at 1) an exerciser volumetric 5000ML device that is utilized to foster improved lung performance in an effort to avoid potential pulmonary post-operative complications, 2) up to two items of cloth, skin prep 2% CHG, a packet of for chlorhexidine gluconate antiseptic cloths utilized by the patient to reduce the risk of surgical site infections by wiping the body in a prescribed manner, 3) up to two Gatorade to help restore the body s electrolytes when fasting prior to surgery.

FDA Recall Z-2480-2018 · Posted None

Recalling FirmCardinal Health 200, LLC
Recall StatusTerminated
Product CodeLRP
Date Initiated2018-02-20
Date Terminated2019-11-04
Product Quantity8,928 kits total

Reason for Recall

A defect in the seal of the Gatorade pouch contained in kits caused the pouch to leak within a limited portion of the kit.

Firm Action

Cardinal Health notified customers via Fed Ex overnight, on about 02/21/2018. The URGENT PRODUCT RECALL letter instructed customers to: 1) Inspect your inventory for the affected product code and lot number; 2)Segregate and quarantine all product on hand; 3) Return enclosed acknowledgment form via fax to 847-689-9101 or 614-652-9648, whether or not you have affected product, indicating the product code, lot and quantity of product youve quarantined; 4) Notify any customers to whom you may have distributed product affected by this recall; 5)Contact Customer Service at 800-964-5227 to arrange return and credit. Customers were also instructed to return any affected kit on site.

Root Cause

Packaging

Distribution Pattern

US Nationwide Distribution in the states of California.

Official Source

View FDA Recall →

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

↑