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Recall Observatory FDA recall evidence

Device product

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

Z-1738-2024

March 27, 2024

Class II

Product summary

Firm
Cardinal Health 200, LLC
Event
Event 94309
Status
Ongoing
Classification
Class II
Quantity
64 cases of 6
Official record key
device-enforcement:Z-1738-2024

Official wording

Reason: 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.

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

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.