—#171781

Product

ChemoPlus Chemo Spill Kit Product Code:DP5016K Product Usage: ChemoPlus chemotherapy spill kits are for the clean-up and containment of chemotherapy spills

FDA product code: LZA — Polymer Patient Examination Glove
Device class: Class 1
Medical specialty: General Hospital
510(k) numbers: K002064
Affected lot / code info: Lot Numbers: 708265X, 709766X, 712108X, 713853X, 719505X, 723645X, 726111X, 727029X, 730304X, 735321X, 803307X, 803990X, 808097X, 809318X, 812914X, 815537X, 821910X, 825016X, 826407X, 833752X

Why it was recalled

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

Root cause (FDA determination)

Nonconforming Material/Component

Action the firm took

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 gmb-fieldcorrectiveaction@cardinalhealth.com for assistance.

Recalling firm

Firm: Cardinal Health
Address: 200 LLC 15 Hampshire St, Bldg 5, Mansfield, Massachusetts 02048-1113

Distribution

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

Timeline

Recall initiated: 2019-03-22
Terminated: 2021-08-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #171781. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.