Z-1738-2024 Class II Ongoing

Recalled by Cardinal Health 200, LLC — Waukegan, IL

FDA device recall Z-1738-2024 was initiated by Cardinal Health 200, LLC on Mar 27, 2024 and is designated Class II. Reason for recall: 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. The recall status is ongoing. Affected quantity: 64 cases of 6.

Recall Details

Product Type
Devices
Report Date
May 8, 2024
Initiation Date
Mar 27, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
64 cases of 6

Product Description

Jackson-Pratt Universal Connector PVC Tubing Anti Reflux Transparent Y, REF SU130-4601

Reason for Recall

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.

Distribution Pattern

Worldwide distribution - US Nationwide and the countries of Panama, Guatemala, Chile, Caribbean Island, Costa Rica.

Code Information

UDI/DI 50192253016459 (Case), 10192253016451 (Each), Lot Numbers: 210751D6

Source

Dataset
openFDA device recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for Z-1738-2024
openFDA file date
Oct 23, 2026
Loaded by RegDataLab
Oct 25, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.