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Recall Observatory FDA recall evidence

Device product

InVision-Plus and InVision-Plus Junior Needleless IV Connector, Disposable, Single Use Products are intended for single patient use in intravenous and blood administration sets without the need for needles, thus eliminating the potential for needle-stick injuries during use.

Z-0675-2016

January 05, 2016

Class II

Product summary

Firm
Rymed Technologies, LLC
Event
Event 72997
Status
Terminated
Classification
Class II
Quantity
496,400 units
Official record key
device-enforcement:Z-0675-2016

Official wording

Reason: Potential for the female luer component of the InVision-Plus IV connector to crack during use.

Code information: InVision-Plus Catalog number RYM-5000 Lots 610, 611, 613, 614; Catalog number RYM-5001 Lots R01777, R01789, R01807, R01817, R01822, R01827, R01839, R01848, R01857, R01860, R01871, and R01874; Catalog number RYM-5001CL Lots R01825, R01887, and R01890. InVision Plus Junior Catalog number RYM-8001 Lot R01853.

Distribution pattern: US Nationwide Distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Potential for the female luer component of the InVision-Plus IV connector to crack during use.