Class 2 Device Recall ChemoPlus Chemo Spill Kit

• Date Initiated by Firm: March 22, 2019
• Create Date: May 06, 2019
• Recall Status: Terminated on August 06, 2021
• Recall Number: Z-1286-2019
• Recall Event ID: 82535
• 510(K)Number: K002064
• Product Classification: Polymer patient examination glove - Product Code LZA
• Product: 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
• Code Information: Lot Numbers: 235609, 303919X, 308148X, 311604X, 312606X, 318318X, 324933X, 328469X, 332206X, 333619X, 400228X, 404307X, 407209X, 410401X, 411560X, 413642X, 421208X, 425562X, 431002X, 433930X, 500815X, 502094X, 508526X, 509804X, 518003X, 523602X, 526504X, 531034X, 535770X, 604188X, 608358X, 611322X, 613451X, 621800X, 625601X, 628817X, 631332X, 634400X, 704641X, 707612X, 711572X, 714407X, 717902X, 723502X, 727719X, 731410X, 735208X, 802308X, 812169X, 815024X, 814519X, 817810X, 827112X, 827610X, 830967X, 833057X
• FEI Number: 3014524790
• Recalling Firm/ Manufacturer: Cardinal Health 200, LLC; 15 Hampshire St Bldg 5; Mansfield MA 02048-1113
• Manufacturer 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
• FDA Determined Cause: Nonconforming Material/Component
• 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 gmb-fieldcorrectiveaction@cardinalhealth.com for assistance.
• Quantity in Commerce: 5415
• Distribution: Worldwide Distribution - US Nationwide: Foreign: Bahamas, Canada, Chile, Guam, Israel, Japan
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = LZA