The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0086-2024·Announced 2023-10-18

Surgical procedure packs containing recalled equipment components distributed nationwide

Cardinal Health is recalling 13,351 surgical procedure packs distributed nationwide that contain recalled components including equipment drapes and table covers.

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: This is an FDA Class II recall with no reported illnesses or injuries. The presence of recalled components within sterile surgical procedure packs represents a risk of harm that has not yet resulted in reported injuries, placing this at the High severity level per the rubric.

Plain-English summary

Cardinal Health 200, LLC is recalling multiple surgical procedure packs under the brand Presource that are distributed across the United States and Canada. The affected packs contain recalled components, specifically equipment drapes, table covers, and surgical room turnover (SRT) kits.

The recalled packs include 16 different catalog numbers and were supplied to various hospitals and medical centers. Approximately 13,351 total packs are affected by this recall. The packs are marked as sterile and are used in surgical procedures.

Healthcare facilities that received these packs should stop using them and contact Cardinal Health for instructions on returning or disposing of the recalled products. Patients who may have been exposed during procedures should contact their healthcare provider if they experience any complications.

The recalled product

Product
Procedure packs: (1) Presource PBDS Cat. PG33BTO21, Ohio State Univ Wexner Med Ctr, Kit, Roux UH, Sterile; (2) Presource PBDS Cat. PG33BTO22, Ohio State Univ Wexner Med Ctr, Kit, Roux UH, Sterile; (3) Presource PBDS Cat. PG33SROUB, Ohio State Univ Wexner Med Ctr, Kit…
Manufacturer
Cardinal Health 200, LLC
Category
Medical Device — Surgical supplies
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. PG33BTO21 - Lot #914590
  • Exp. 6/1/2024
  • UDI-DI 10195594884130
  • (2) Cat. PG33BTO22 - Lot #928313
  • Exp. 2/1/2024
  • UDI-DI 10197106010419
  • (3) Cat. PG33SROUB - Lot #81580
  • Exp. 12/1/2024
  • UDI-DI 10197106186930
  • (4) Cat. PUMHCCESP - Lot #4316
  • Exp. 2/1/2025 and 9/1/2025
  • UDI-DI 10195594542153
  • (5) Cat. SBA18GLEFF - Lot #895495
  • Exp. 6/1/2025 and Exp. 7/1/2025
  • UDI-DI 10888439910209
  • (6) Cat. SOTCGPPMEA - Lot #984246
  • Exp. 7/1/2025 and Exp. 5/1/2024
  • UDI-DI 10888439847475
  • (7) Cat. SOT18CYEFC - Lot #928044
  • Exp. 4/1/2027

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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