FDA Medical Device Recalls (openFDA)
Cardinal Health 200, LLC: ChemoPlus Protective Wrap-around Goggles Product Code:DP5030G Product Usage: ChemoPlus chemotherapy spill kits are for the clean-up and containment of chemotherapy spills
- Recall number
- Z-1285-2019
- Recalling firm
- Cardinal Health 200, LLC
- Product
- ChemoPlus Protective Wrap-around Goggles Product Code:DP5030G Product Usage: ChemoPlus chemotherapy spill kits are for the clean-up and containment of chemotherapy spills
- Status
- Terminated
- Initiated
- 2019-03-22
- Posted
- not on file
- Terminated
- 2021-08-06
- Reason
- 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
- 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
- 3236
- Distribution
- Worldwide Distribution - US Nationwide: Foreign: Bahamas, Canada, Chile, Guam, Israel, Japan
- Lot, serial or model codes
- Lot Numbers: 235508X, 303205X, 305701X, 307708X, 308126X, 309206X, 319602X, 320504X, 323204X, 410837X, 413643X, 414326X, 416430X, 422701X, 430016X, 430442X, 431828X, 434226X, 434528X, 506449X, 619595X, 622266X, 624614X, 625363X, 629806X, 703411X, 705165X, 706224X, 708004X, 710351X, 712123X, 719186X, 720507X, 723650X, 729905X, 734723X, 803018X, 812171X, 817809X, 823430X, 825704X, 826721X
- 510(k) numbers
- ["K002064"]
- PMA numbers
- not on file
- Product code
- LZA
- Firm FEI
- 3014524790
- Firm city
- Mansfield
- Firm state
- MA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28