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Recall Observatory FDA recall evidence

Device product

Shoulder, SESH18I; Medical convenience kit

Z-3232-2024

August 07, 2024

Class II

Product summary

Firm
American Contract Systems, Inc.
Event
Event 95261
Status
Ongoing
Classification
Class II
Quantity
60 units
Official record key
device-enforcement:Z-3232-2024

Official wording

Reason: ACS identified that due to an inoperable chart recorder, humidity readings were out-of-specification in one of the controlled environment areas. As a result, ACS is unable to confirm product sterilization assurance requirements were met.

Code information: UDI-DI: 00191072198532; Lot: 2405112; Exp: 05/11/2025

Distribution pattern: US Nationwide distribution in the states of MO, MN, MA, OH, NE.

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    out-of-specification