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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Device
Medical Devices/Surgical Equipment

Cardinal Health 200, LLC: Cardinal Health Surgical Packs Recalled Due to Faulty Components

Agency Publication Date: October 10, 2023
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Summary

Cardinal Health 200, LLC is recalling 133,510 surgical procedure packs because they contain recalled components including equipment drapes, table covers, and surgical room turnover (SRT) kits. These packs are used across various medical procedures ranging from orthopedic and neurosurgery to cardiac and vascular labs. Consumers and healthcare providers should identify these packs by their specific catalog and lot numbers to prevent the use of compromised equipment during surgery.

Risk

The use of recalled components within these surgical packs may compromise the sterile field or fail to provide the intended protection during medical procedures. While no specific injuries were mentioned, using faulty equipment drapes or turnover kits can lead to procedural delays or potential exposure to non-sterile environments.

What You Should Do

  1. Check your medical inventory immediately for Presource surgical packs including Pain Trays, Block Trays, Endovascular Kits, Pacemaker Packs, and C-Section Kits matching the catalog and lot numbers provided in the affected products list.
  2. Identify affected lots by looking for catalog numbers such as SBAHFPTAS2 (Lot 900813), SNE37ANMOF (Lot 32724), and dozens of other specific codes with expiration dates ranging from early 2024 through mid-2027.
  3. Stop using any surgical packs identified as part of this recall immediately to avoid risks associated with the faulty drapes or table covers.
  4. Isolate and quarantine all affected products to ensure they are not used in clinical settings.
  5. Contact Cardinal Health 200, LLC at their Waukegan, Illinois headquarters or through your dedicated representative to discuss return procedures and potential replacements.
  6. Consult with your healthcare provider or hospital administration if you have concerns regarding procedures where these packs may have been used.
  7. For further information or questions regarding this device recall, contact the FDA at 1-888-463-6332 or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

healthcare provider or manufacturer consultation

How to: Contact your healthcare provider or the manufacturer for further instructions and potential refund

Affected Products

Product: Presource Pain Tray, Advanced Surgery Center SAR
Model / REF:
SBAHFPTAS2
UPC Codes:
10195594810351
Lot Numbers:
900813
Date Ranges: Exp. 1/1/2025
Product: Presource Block Tray, Medical Center Odessa
Model / REF:
SNE37ANMOF
UPC Codes:
10195594576080
Lot Numbers:
32724
Date Ranges: Exp. 4/1/2025
Product: Presource PBDS Extraction Ross Kit
Model / REF:
PC71EXOU7
UPC Codes:
10195594873332
Lot Numbers:
916915
Date Ranges: Exp. 5/1/2024
Product: Presource PBDS Endovascular Kit, Bellevue Hospital Center
Model / REF:
PVOCMVBLC
UPC Codes:
10195594763183
Lot Numbers:
922978
Date Ranges: Exp. 10/1/2024, Exp. 7/1/2024
Product: Presource PBDS Dr. Ross Minor Vascular Kit
Model / REF:
PVRMMVAOH7
UPC Codes:
10195594892777
Lot Numbers:
923996
Date Ranges: Exp. 1/1/2024
Product: Presource PBDS Tavi Kit
Model / REF:
PV30VPUHA
UPC Codes:
10195594485894
Lot Numbers:
898892
Date Ranges: Exp. 2/1/2024
Product: Presource Cat Pack, DMAC Vascular Lab LLC
Model / REF:
SANOCCPDM2
UPC Codes:
10195594882273
Lot Numbers:
920122
Date Ranges: Exp. 6/1/2025
Product: Presource Pacemaker Pack, U of L Health
Model / REF:
SAN1FPMULM
UPC Codes:
10195594712938
Lot Numbers:
929016
Date Ranges: Exp. 6/1/2024
Product: Presource OR Angio Pack, Suny Downstate
Model / REF:
SAN11OADMM
UPC Codes:
10195594553562
Lot Numbers:
985859
Date Ranges: Exp. 11/1/2025
Product: Presource Device Implant Pack, BILH Lahey Hospital
Model / REF:
SAN13DILCO
UPC Codes:
10888439914443
Lot Numbers:
936019
Date Ranges: Exp. 8/1/2024
Product: Presource ENT Kit, Southeast Hospital MHHS
Model / REF:
PEMHEEESR
UPC Codes:
10195594543259
Lot Numbers:
967679
Date Ranges: Exp. 9/1/2024
Product: Presource C Section B Kit, Hermann Hospital MHHS
Model / REF:
PLMHCSBHF
UPC Codes:
10195594542795
Lot Numbers:
81461
Date Ranges: Exp. 6/1/2024, Exp. 9/1/2024
Product: Presource Fistulogram Pack, Hartford Hospital
Model / REF:
SANOCFGHHA
UPC Codes:
10888439920840
Lot Numbers:
23520
Date Ranges: Exp. 2/1/2025

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 92875
Status: Active
Manufacturer: Cardinal Health 200, LLC
Sold By: Advanced Surgery Center SAR; Medical Center Odessa; Ohio State Univ Wexner Med Ctr; Bellevue Hospital Center; Regional Medical Center; Univ Hlth Net Toronto Gen Hosp; DMAC Vascular Lab LLC; U of L Health; Suny Downstate; BILH Lahey Hospital Burlington; CHI Memorial Hospital Chattano; Ballad Health; Catawba Valley Medical Center; Cleveland Clinic Health System; KP Oakland Med Center; Trillium Health Centre; Vancouver General Hospital; Jewish Hospital; St. Francis Hospital; Doctors Hospital; Virginia Mason Medical Center; KP Maui Memorial Medical Cente; Salem Health; KP Baldwin Park Med Cntr; Starling Physicians Access Cen; Henry Ford Health System; Thomas Jefferson University; Richmond Hospital; Health Science Centre; Southeast Hospital MHHS; St. Elizabeth Medical Center; Hillcrest Hospital; North Bay Regional Hlth Ctr; Lehigh Valley Hospital; KP Zion Med Cntr; Parkview Medical Center; Englewood Hospital and Medical; AHS Calgary Zone; Moffitt Cancer Center; Lakeridge Health Corporation; Sequoia Surgery Center LLC; Medstar Franklin Square Med CE; Medstar Georgtown University H; Hartford Hospital
Manufactured In: United States
Units Affected: 10 products (13,351 total packs)
Distributed To: Arizona, California, Colorado, Connecticut, District of Columbia, 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, West Virginia

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.