Cardinal Health Recalls ChemoPlus Chemo Spill Kits Due to Latex
Cardinal Health 200, LLC is recalling ChemoPlus Chemo Spill Kits because the safety goggles inside contain natural rubber latex, despite the kit label stating the product is latex-free.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a mislabeling of a common allergen (natural rubber latex) on a medical device, which fits the rubric criteria for 'Allergen mislabeling on common allergens' (Score 3).
Plain-English summary
Cardinal Health 200, LLC is recalling 5,415 units of ChemoPlus Chemo Spill Kits, Home Health Kit (Product Code: DP5108K). These kits are designed for the clean-up and containment of chemotherapy spills. The recall is being conducted because the safety goggles included within the kits contain natural rubber latex in the goggle strap, even though the kit label states that the product is not made with natural rubber latex.
The affected products were distributed nationwide in the United States and internationally to the Bahamas, Canada, Chile, Guam, Israel, and Japan. The recall covers specific lot numbers, including 235609, 303919X, 308148X, and others listed in the official recall notice.
Consumers and healthcare providers should check their inventory for these specific lot numbers. If you have a latex allergy, do not use the safety goggles from these kits. Contact Cardinal Health 200, LLC for further instructions on how to return or replace the affected products.
The recalled product
- 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
- Manufacturer
- Cardinal Health 200, LLC
- Affected units
- 5,415
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Lot Numbers: 235609
- 303919X
- 308148X
- 311604X
- 312606X
- 318318X
- 324933X
- 328469X
- 332206X
- 333619X
- 400228X
- 404307X
- 407209X
- 410401X
- 411560X
- 413642X
- 421208X
- 425562X
- 431002X
- 433930X
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Cardinal Health 200, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
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