The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0089-2024·Announced 2023-10-18

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.

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 3/5 (High).

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)…
Manufacturer
Cardinal Health 200, LLC
Category
Medical Device — Surgical Procedure Kits
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. 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.

The notice also names 34 states specifically:

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 →

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