The Recall Desk
ModerateFDA (Devices)·Z-1079-2021·Announced 2021-02-17

Cardinal Health Recalls Chembloc Preparation Kits Due to Gown Defects

Cardinal Health is recalling Chembloc Preparation and Administration Kits because the included gowns may have rips, holes, or foreign material.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, but the defects (rips, holes, debris) are quality control issues without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Cardinal Health 200, LLC is recalling 137,346 units of the CHEMOBLOC Preparation and Administration Kit, Extra Large Blue Gown, Medium and Large Gloves, Nonsterile, SKU DP5106K. The recall affects Lot 911609X, which was distributed globally and nationwide in the United States.

The recall was initiated because the gowns included in these kits potentially have rips, holes, tears, incomplete and/or open seams, staining, foreign material, or debris. These defects may compromise the integrity of the protective barrier intended for use during chemotherapy preparation and administration.

Healthcare facilities and consumers who have this specific product should stop using it and contact Cardinal Health for further instructions or a return.

The recalled product

Product
CHEMOBLOC Preparation and Administration Kit, Extra Large Blue Gown, Medium and Large Gloves, Nonsterile, SKU DP5106K
Affected units
137,346

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 (1)

  • Lot: 911609X

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 6 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 6 products in this recall →