Surgical Procedure Packs Recalled Due to Recalled Components
Cardinal Health is recalling 13,351 surgical procedure packs containing previously recalled components including equipment drapes, table covers, and surgical room turnover kits distributed nationwide in the US and Canada.
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: FDA Class II medical device recall with no reported illnesses or injuries. The recall appears precautionary due to incorporation of previously recalled components, without a specified defect mechanism or reported patient harm.
Plain-English summary
Cardinal Health 200, LLC is recalling 13,351 surgical procedure packs that contain recalled components. The affected products include equipment drapes, table covers, and surgical room turnover kits packaged into various procedure kits used for different surgical procedures.
The recalled procedure packs were distributed nationwide across multiple US states (including 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) as well as Canada. The packs were distributed to hospitals and medical facilities.
Healthcare providers who received these procedure packs should stop use and verify whether they have received any of the affected products. Patients who may have been treated with materials from these procedure packs should consult with their healthcare provider if they have concerns.
The recalled product
- Product
- Procedure packs: (1) Presource PBDS, Cat. PGMHSUESR, Southeast Hospital MHHS, Kit, Set Up No Drape, SE, Sterile; (2) Presource PBDS Cat. PGVGLBP20, Parkview Medical Center, Kit, Lap Chole, Sterile; (3) Presource PBDS Cat. PG63CCC31, USPI Christ Hosp Spine Srgry C, Kit, Basic
- Manufacturer
- Cardinal Health 200, LLC
- Hazard
- recalled-components
- equipment-defect
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. PGMHSUESR - Lot #54698
- Exp. 2/1/2025 and Exp. 6/1/2024
- UDI-DI 10195594542757
- (2) Cat. PGVGLBP20 - Lot #921831
- Exp. 4/1/2024
- UDI-DI 10195594892210
- (3) Cat. PG63CCC31 - Lot #940845
- Exp. 9/1/2023
- UDI-DI 10197106032978
- (4) Cat. PG63CCC34 - Lot #46817
- Exp. 2/1/2024
- UDI-DI 10197106279342
- (5) Cat. SBAOCRBENF - Lot #985693
- Exp. 7/1/2024
- UDI-DI 10195594735999
- (6) Cat. SBAOCRBEN8 - Lot #920306
- Exp. 6/1/2024
- UDI-DI 10195594882334
- (7) Cat. SBA30MJCHH - Lot #937398
- Exp. 4/1/2025
Distribution
Distributed nationwide across the United States.
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