Device product
InVision-Plus CS Needleless IV Connector, Catalog Number RYM-7001. 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-0676-2016
Product summary
- Event
- Event 72997
- Status
- Terminated
- Classification
- Class II
- Quantity
- 46,600 units
- Official record key
device-enforcement:Z-0676-2016
Official wording
Reason: Potential for the female luer component of the InVision-Plus IV connector to crack during use.
Code information: Catalog number RYM-7001 Lots: R01842, R01889, R01891, and R01897, Expire 03/2016.
Distribution pattern: US Nationwide Distribution.
Derived failure modes
-
Unknown
Potential for the female luer component of the InVision-Plus IV connector to crack during use.