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Recall Observatory FDA recall evidence

Device product

Jackson-Pratt 3-Spring Reservoir with Silicone Adapters, 400mL, REF SU130-475

Z-1739-2024

March 27, 2024

Class II

Product summary

Firm
Cardinal Health 200, LLC
Event
Event 94309
Status
Ongoing
Classification
Class II
Quantity
98 cases of 12
Official record key
device-enforcement:Z-1739-2024

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 50885380113114 (Case), 10885380113116 (Each), Lot Numbers: 231251D5

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.