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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: Jackson-Pratt 3-Spring Reservoir Kits Recalled for Lack of Sterilization

Agency Publication Date: May 1, 2024
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Summary

Cardinal Health is recalling approximately 3,397 Jackson-Pratt 3-Spring Reservoir kits because specific lots were shipped to users before undergoing required sterilization. These medical devices are typically used for post-surgical drainage, and using a non-sterile device can introduce bacteria or other contaminants directly into a patient's body. Consumers and healthcare providers should check for specific lot numbers of the 400mL kits, universal connectors, and silicone adapter models distributed worldwide.

Risk

Using a non-sterile surgical drainage device poses a significant risk of localized or systemic infection, as the device is placed in direct contact with internal tissues and fluids. No specific injuries have been reported to date, but the lack of sterilization is a serious manufacturing defect that can lead to surgical site complications.

What You Should Do

  1. Check your surgical supplies for Jackson-Pratt 3-Spring Reservoir Kits, specifically REF numbers SU130-401D, SU130-402D, SU130-403D, SU130-4601, and SU130-475.
  2. Identify if your product is affected by matching the lot numbers on the packaging: 231251D1, 231151D1, 210751D1 (7Fr. Kit); 231251D2 through 231256D2, 231151D2 through 231153D2, 210751D2 through 210755D2 (10Fr. Kit); 210751D3 (15Fr. Kit); 210751D6 (Universal Connector); or 231251D5 (Silicone Adapter Reservoir).
  3. Immediately stop using any affected products that are currently in your inventory and quarantine them to prevent further use.
  4. Contact your healthcare provider or Cardinal Health at 1-888-463-6332 for further instructions regarding the return or disposal of the non-sterile kits and to arrange for replacements or potential refunds.
  5. If you have already used one of these affected lots in a patient, monitor the patient closely for signs of infection and consult with a medical professional.
  6. For additional questions or to report a problem, contact the FDA at 1-888-463-6332 (1-888-INFO-FDA) or visit www.fda.gov/medical-devices/medical-device-recalls.

Your Remedy Options

๐Ÿ“‹Other Action

Voluntary removal from the market.

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

Affected Products

Product: Jackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain, 400mL, 7Fr.
Model / REF:
REF SU130-401D
UPC Codes:
50192253016411
20192253016410
10192253016413
Lot Numbers:
231251D1
231151D1
210751D1
Product: Jackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain, 400mL, 10Fr.
Model / REF:
REF SU130-402D
UPC Codes:
50192253016428
20192253016427
10192253016420
Lot Numbers:
231251D2
231252D2
231253D2
231254D2
231255D2
231256D2
231151D2
231152D2
231153D2
210751D2
210752D2
210753D2
210754D2
210755D2
Product: Jackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain, 400mL, 15Fr.
Model / REF:
REF SU130-403D
UPC Codes:
50192253016435
20192253016434
10192253016437
Lot Numbers:
210751D3
Product: Jackson-Pratt Universal Connector PVC Tubing Anti Reflux Transparent Y
Model / REF:
REF SU130-4601
UPC Codes:
50192253016459
10192253016451
Lot Numbers:
210751D6
Product: Jackson-Pratt 3-Spring Reservoir with Silicone Adapters, 400mL
Model / REF:
REF SU130-475
UPC Codes:
50885380113114
10885380113116
Lot Numbers:
231251D5

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94309
Status: Active
Manufacturer: Cardinal Health 200, LLC
Sold By: Direct distribution; Healthcare facilities
Manufactured In: United States
Units Affected: 5 products (202 cases of 12; 2905 cases of 12; 128 cases of 12; 64 cases of 6; 98 cases of 12)
Distributed To: Nationwide

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.

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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.