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Recall Observatory FDA recall evidence

Device product

CENTRAL LINE PICC , Model No LLCL44H LLCL44H-01

Z-1343-2025

February 06, 2025

Class II

Product summary

Firm
American Contract Systems Inc
Event
Event 96343
Status
Ongoing
Classification
Class II
Quantity
1420
Official record key
device-enforcement:Z-1343-2025

Official wording

Reason: ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.

Code information: UDI-DI 00191072219602 Lots 70-050707 70-050860 70-051149 70-051713 70-052363 70-053044

Distribution pattern: US Nationwide distribution in the state of OH.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    ACS is unable to confirm product sterilization assurance requirements were met. Possible loss or lack of functionality may lead to delay or prolonged treatment.