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Recall Observatory FDA recall evidence

Device product

Jackson-Pratt 3-Spring Reservoir Kit with PVC Round Drain, 400mL, 10Fr., REF SU130-402D

Z-1736-2024

March 27, 2024

Class II

Product summary

Firm
Cardinal Health 200, LLC
Event
Event 94309
Status
Ongoing
Classification
Class II
Quantity
2905 cases of 12
Official record key
device-enforcement:Z-1736-2024

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 50192253016428 (Case), 20192253016427 (Box), 10192253016420 (Each), Lot Numbers: 231251D2, 231252D2, 231253D2, 231254D2, 231255D2, 231256D2, 231151D2, 231152D2, 231153D2, 210751D2, 210752D2, 210753D2, 210754D2, 210755D2

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.