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Jackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain… recallZ-1735-2024 · Cardinal Health 200, LLC · initiated Mar 27, 2024

Open, Classified

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Cardinal Health 200, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

Cardinal Health is issuing a lot number specific voluntary removal of Jackson-Pratt 3-Spring Reservoir kits due to specific products being shipped to users before undergoing sterilization.

FDA root cause category: Under Investigation by firm

What the company is doing

Cardinal Health issued an URGENT MEDICAL DEVICE PRODUCT RECALL notice to its consignees on 03/27/2024 via overnight mail. The notice explained the issue, potential hazard, and requested the following: Locate, segregate, and cease use of the affected product, disseminate the notice to those who handle the product. Distributors were directed to notify their customers. CONTACT the appropriate Customer Service group to arrange return of product and with questions related to this notification. Monday Friday between 8:00am - 5pm EST: " Hospital 800-964-5227 " Federal Government 800-444-1166 " Distributor 800-635-6021 " All Other Customers 888-444-5440 For questions related to this notification and/or acknowledgement form that are not adequately addressed in this letter, please contact the market action team at: [email protected] or call 800-292-9332.

Recall details

Recall number
Z-1735-2024
Status
Open, Classified
Initiated by the company
Mar 27, 2024
Posted by the FDA
May 1, 2024
Recalling firm
Cardinal Health 200, LLC
Quantity
202 cases of 12
Product code
GBX
Distribution
Worldwide distribution - US Nationwide and the countries of Panama, Guatemala, Chile, Caribbean Island, Costa Rica.

Product description

Jackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain, 400mL, 7Fr., REF SU130-401D

Code information (models, lots, serial numbers)

UDI/DI 50192253016411 (Case), 20192253016410 (Box), 10192253016413 (Each), Lot Numbers: 231251D1, 231151D1, 210751D1

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Other products in the same recall event

The FDA groups related products into one recall event (event 94309).

Sources and updates

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