Z-0675-2016 Class II Terminated
FDA device recall Z-0675-2016 was initiated by Rymed Technologies, LLC on January 5, 2016 and is designated Class II. Reason for recall: Potential for the female luer component of the InVision-Plus IV connector to crack during use. The recall status is terminated (terminated October 19, 2016). Affected quantity: 496,400 units.
Recall Details
- Product Type
- Devices
- Report Date
- January 27, 2016
- Initiation Date
- January 5, 2016
- Termination Date
- October 19, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 496,400 units
Product Description
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.
Reason for Recall
Potential for the female luer component of the InVision-Plus IV connector to crack during use.
Distribution Pattern
US Nationwide Distribution.
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.