Z-0675-2016Class II

InVision-Plus and InVision-Plus Junior Needleless IV Connector, Disposable, Single Use Products are intended...

Name: Z-0675-2016 InVision-Plus and InVision-Plus Junior Needleless IV Connector, Disposable, Single Use Products are intended...
Creator: Rymed Technologies, LLC
Published: 2016-01-05
License: https://open.fda.gov/license/

RyMed Technologies, LLC / initiated 2016-01-05 / Terminated / root cause: manufacturing process

FDA source

Rymed Technologies, LLC began a recall of InVision-Plus and InVision-Plus Junior Needleless IV Connector, Disposable, Single Use Products are intended for single patient use in intravenous and blood... on 2016-01-05. FDA classified it as Class II and gives the reason as "Potential for the female luer component of the InVision-Plus IV connector to crack during use". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0675-2016
Classification: Class II
Status: Terminated
Initiated: 2016-01-05
Posted: 2016-01-21
Terminated: 2016-10-19
Recalling firm: RyMed Technologies, LLC
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.
Product code: FPA Set, Administration, Intravascular
Reason for recall: Potential for the female luer component of the InVision-Plus IV connector to crack during use.
Root cause tag: manufacturing process
FDA root cause: Process design
Action: The firm Ry Med Technology LLC, sent an "URGENT: MEDICAL DEVICE RECALL" letter dated January 4, 2016 and response form to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to discontinue use and return the product to: RyMed Technologies LLC, 6000 W. William Cannon Drive, Building B, Suite 300 Austin, TX 78749; the user facilities to change the IV connectors in 24 hour when lipids are being administered; if further distributed, contact other accounts, advise of recall and return outstanding stock; complete and return the RECALL NOTIFICATION ASAP and no later than 10 business day via email to: [email protected], fax to: 512-301-7338, Attention Recall Return Notification or mail to RyMed Technologies LLC, Attention Recall Return Notification, 6000 W. William Cannon, Building B, Suite 300 Austin, TX 78749. If you have any questions concerning the recall, contact Director of Quality Assurance/Regulatory Affairs by email to: [email protected] or call 512-301-7338x303. If you have questions about returning/replacement of product contact Logistics Specialist by email to: [email protected] or call 512-301-7338x309.
Quantity in commerce: 496,400 units
Distribution: US Nationwide Distribution.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0675-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0675-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-27	2016-01-21
Z-0676-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-27	2016-01-21

Product code FPA

K991653Class IIInvision-Plus Injection Port Connector SystemRymed Technologies, Inc. / cleared 1999-06-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)