Cardinal Health Recalls Surgical Procedure Packs Due to Defective Components
Cardinal Health is recalling 13,351 surgical procedure packs distributed nationwide and in Canada. The packs contain recalled equipment drapes, table covers, and surgical room turnover kits.
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: These surgical procedure packs are used in sterile operating room environments for spinal and neurological procedures, making them inherently high-risk products. Although no illnesses or injuries have been reported, the packs contain recalled components with known defects, satisfying the criterion of risk-of-harm products where injury has not yet been reported.
Plain-English summary
Cardinal Health 200, LLC is recalling 13,351 Presource surgical procedure packs. The packs are used for spinal, neurological, and other surgical procedures. They contain equipment drapes, table covers, and surgical room turnover kits that are recalled components with known defects.
The affected packs were distributed nationwide throughout the United States and in Canada. The recall includes 47 different procedure pack models with specific lot numbers and expiration dates ranging from 2023 to 2025.
Healthcare facilities that have received these packs should identify and quarantine affected inventory using the lot numbers and product codes provided. Contact the manufacturer or consult FDA recall notice Z-0089-2024 for guidance on replacement or return procedures.
The recalled product
- Product
- Procedure packs: (1) Presource PBDS Cat. PNVMNIB21, Kit, Neuro IMAS, Sterile; (2) Presource PBDS Cat. PN08LAG13, Kit, Spine, Sterile; (3) Presource PBDS Cat. PN08LAG17, Kit, Spine, Sterile; (4) Presource PBDS, Cat. PN11SFS40, Kit, Thoracolumbar Fusion, Sterile; (5) Presour
- Manufacturer
- Cardinal Health 200, LLC
- Hazard
- surgical-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. PNVMNIB21 - Lot #920364
- Exp. 6/1/2024
- UDI-DI 10195594891879
- (2) Cat. PN08LAG13 - Lot #920368
- UDI-DI 10195594886516
- (3) Cat. PN08LAG17 - Lot #987136
- Exp. 11/1/2024
- UDI-DI 10197106132944
- (4) Cat. PN11SFS40 - Lot #917897
- UDI-DI 10195594875060
- (5) Cat. PN33DBOU3 - Lot #918902
- Exp. 8/1/2023
- UDI-DI 10195594878627
- (6) Cat. PN40CD806 - Lot #17765
- Exp. 5/1/2024
- UDI-DI 10197106202968
- (7) Cat. PN73APVDE - Lot #936774
- Exp. 9/1/2023
- UDI-DI 10195594742065
- (8) Cat. PN73APVD7 - Lot #931972
Distribution
Distributed nationwide across the United States.
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