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Recall Observatory FDA recall evidence

Device product

smiths medical portex, 15mm Double Swivel Connector: a) REF 100/255/150; b) REF 100/255/150JP; c) REF 100/255/150 JS

Z-0144-2025

July 18, 2024

Class II

Product summary

Firm
Smiths Medical ASD Inc.
Event
Event 95181
Status
Ongoing
Classification
Class II
Quantity
34,141 units
Official record key
device-enforcement:Z-0144-2025

Official wording

Reason: Uncertainty in the seal integrity of the sterile packaging.

Code information: a) REF 100/255/150, UDI/DI 35019315022399, Lot Numbers: 4125006; UDI/DI 35019315010990, Lot Numbers: 4159808, 4161750; UDI/DI 35019315011003, Lot Numbers: 4131840; UDI/DI 35019315018156, Lot Numbers: 4131559; UDI/DI 35019315022405, Lot Numbers: 4122011, 4127688; b) REF 100/255/150JP, UDI/DI 35019315010990, Lot Numbers: 4089148, 4107293, 4122008, 4147817, 4138707, 4159808; c) REF 100/255/150 JS, UDI/DI 35019315010990, Lot Numbers: 4122008, 4147817, 4159808

Distribution pattern: Worldwide distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Uncertainty in the seal integrity of the sterile packaging.