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Terminated

ChemoPlus Chemo Spill Kit, Home Health Kit Product Code:DP5108K Product Usage: ChemoPlus chemotherapy spill kits are for the clean-up and containment of chemotherapy spills

FDA Recall Z-1286-2019 · Posted None

Recall StatusTerminated
Product CodeLZA
Date Initiated2019-03-22
Date Terminated2021-08-06
Product Quantity5415

Reason for Recall

Kit label states not made with natural rubber latex,however safety goggles within the kits contain natural rubber latex in the goggle strap

Firm Action

Cardinal Health issued recall letter dated March 22, 2019 stating reason for recall, health risk and Action Required: 1. INSPECT inventory.2. SEGREGATE and QUARANTINE all on-hand product. 3. RETURN the 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 or discarded. 4. NOTIFY customers to whom you may have distributed, or forwarded product affected by this recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter. 5. CONTACT the appropriate Customer Service group to arrange for return and credit of any affected product Monday Friday between 8:00am - 5:00pm EST: Hospital800-964-5227 Federal Government800-444-1166 Distributor800-635-6021 All other customers888-444-5440. On 4/17/19 the firm issued the Correction Letter action and provided sticker labels-stating Warning Product contains natural rubber latex which may cause an allergic reaction. Action to take: INSPECT your inventory for the affected product code and lot number (listed on package) .SEGREGATE and QUARANTINE all on-hand product. 3. AFFIX the enclosed warning label on the principal display panel over the current not made with natural latex labeling (if applicable) on affected kits as shown in example 1. 4. ADDITIONAL labels can be obtained by contacting 800-292-9332 or [email protected] for assistance.

Root Cause

Nonconforming Material/Component

Distribution Pattern

Worldwide Distribution - US Nationwide: Foreign: Bahamas, Canada, Chile, Guam, Israel, Japan

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

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

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