Cardinal Health recalls procedure packs containing defective components
Cardinal Health is recalling 13,351 Presource PBDS surgical procedure packs (Lot #967679) containing defective equipment drapes, table covers, and surgical room turnover kits distributed nationwide and in Canada.
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 2/5 (Moderate).
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: This is a Class II medical device recall. The source material does not report any illnesses, injuries, or documented adverse events. The specific nature of the defect is not detailed. Without evidence of harm and with limited hazard information, this recall is classified as Moderate.
Plain-English summary
Cardinal Health is recalling 13,351 Presource PBDS surgical procedure packs (Lot #967679, expiration 9/1/2024, UDI-DI 10195594543259). The packs contain equipment drapes, table covers, and surgical room turnover kits. This is a Class II recall issued by the FDA.
The recalled packs were distributed nationwide across 32 U.S. states, Washington D.C., and Canada. Healthcare facilities and surgical centers in these locations may have received the affected lot.
Healthcare providers should check their inventory for Lot #967679 and contact Cardinal Health for information about replacement or proper disposition of the recalled products. The FDA recall number is Z-0085-2024.
The recalled product
- Product
- Procedure pack: Presource PBDS, Cat. PEMHEEESR, Southeast Hospital MHHS, Kit, ENT, SE, Sterile.
- Manufacturer
- Cardinal Health 200, LLC
- Hazard
- Affected units
- 13,351
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 (3)
- Lot #967679
- Exp. 9/1/2024
- UDI-DI 10195594543259.
Distribution
Part of a larger recall action
This product is one of 10 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 10 products in this recall →Related recalls
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