Cardinal Health procedure packs recalled for containing previously recalled components
Cardinal Health is recalling surgical procedure packs that contain previously recalled components including equipment drapes, table covers, and surgical room turnover kits. Approximately 13,351 packs were distributed nationwide and in Canada.
What this means for you
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: Medical device procedure packs containing previously recalled surgical components represent a risk-of-harm scenario. FDA Class II classification indicates hazards requiring corrective action; no patient injuries or hospitalizations have been reported in this recall notice.
Plain-English summary
Cardinal Health 200, LLC is recalling surgical procedure packs because they contain previously recalled components. The affected products are the Presource Pain Tray (Catalog SBAHFPTAS2, Lot #900813, expiring 1/1/2025) and the Presource Block Tray (Catalog SNE37ANMOF, Lot #32724, expiring 4/1/2025). These packs contain recalled equipment drapes, table covers, and surgical room turnover kits.
Approximately 13,351 procedure packs were distributed across 33 U.S. states, Canada, and to government facilities. Affected states include 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.
This is a Class II FDA recall issued due to the inclusion of recalled components in surgical procedure packs.
The recalled product
- Product
- Procedure packs: (1) Presource Pain Tray, Catalog SBAHFPTAS2, Advanced Surgery Center SAR, Sterile. (2) Presource Block Tray, Catalog SNE37ANMOF, Medical Center Odessa.
- Manufacturer
- Cardinal Health 200, LLC
- Hazard
- recalled-components
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 (6)
- (1) Cat. SBAHFPTAS2 - Lot #900813
- exp. 1/1/2025
- UDI-DI 10195594810351
- and (2) Cat. SNE37ANMOF - Lot #32724
- exp. 4/1/2025
- UDI-DI 10195594576080.
Distribution
Distributed nationwide across the United States.
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