Cardinal Health surgical procedure packs recalled for defective components
Cardinal Health is recalling 13,351 surgical procedure packs containing recalled components including equipment drapes, table covers, and surgical room turnover kits.
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: FDA Class II recall with no reported illnesses, injuries, or detailed hazard specification stated in the source. Per the rubric, recalls with theoretical hazards and no reported harm are classified as Moderate.
Plain-English summary
Cardinal Health 200, LLC is recalling 13,351 surgical procedure packs that contain recalled components, including equipment drapes, table covers, and surgical room turnover (SRT) kits used in surgical procedures at healthcare facilities.
The affected packs have been distributed nationwide across 34 U.S. states (Arizona, California, Colorado, Connecticut, Washington DC, Florida, Hawaii, Idaho, Illinois, Indiana, Kansas, Kentucky, Louisiana, Massachusetts, Maryland, Michigan, Minnesota, Missouri, Montana, North Carolina, Nebraska, New Jersey, Nevada, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, Tennessee, Texas, Virginia, Washington, and West Virginia) and in Canada. Multiple lots with specific expiration dates have been identified.
Healthcare facilities that received these recalled packs should immediately discontinue use and contact Cardinal Health for return or replacement instructions. Healthcare providers should report any adverse events or concerns to the FDA.
The recalled product
- Product
- Procedure packs: (1) Presource PBDS, Cat. PC71EXOU7, Ohio State Univ Wexner Med Ctr, Kit, Extraction Ross, Sterile; (2) Presource PBDS, Cat. PVOCMVBLC, Bellevue Hospital Center, Kit, Endovascular. (3) Presource PBDS, Cat. PVRMMVAOH7, Regional Medical Center of, Kit, Dr.…
- 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 (20)
- (1) Cat. PC71EXOU7 - Lot #916915
- Exp. 5/1/2024
- UDI-DI 10195594873332
- (2) Cat. PVOCMVBLC - Lot #922978
- Exp. 10/1/2024
- and Lot #922978
- Exp. 7/1/2024
- UDI-DI 10195594763183
- (3) Cat. PVRMMVAOH7 - Lot #923996
- Exp. 1/1/2024
- UDI-DI 10195594892777
- (4) Cat. PV30VPUHA - Lot #898892
- Exp. 2/1/2024
- UDI-DI 10195594485894
- (5) Cat. SANOCCPDM2 - Lot #920122
- Exp. 6/1/2025
- UDI-DI 10195594882273
- (6) Cat. SAN1FPMULM - Lot #929016
- Exp. 6/1/2024
- UDI-DI 10195594712938
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.
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