The Recall Desk
HighFDA (Devices)·Z-0676-2016·Announced 2016-01-27

Rymed InVision-Plus IV Connector Recall Due to Cracking Risk

Rymed Technologies is recalling 46,600 InVision-Plus CS Needleless IV Connectors because the female luer component may crack during use.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a medical device with a structural defect (cracking) that poses a risk of harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Rymed Technologies, LLC is recalling 46,600 units of the InVision-Plus CS Needleless IV Connector, Catalog Number RYM-7001. These are disposable, single-use medical devices intended for intravenous and blood administration sets. The recall covers specific lots (R01842, R01889, R01891, and R01897) with an expiration date of 03/2016.

The recall was initiated because the female luer component of the connector has the potential to crack during use. The products were distributed nationwide in the United States.

Healthcare providers and facilities should stop using the affected lots and contact Rymed Technologies for instructions on returning the devices.

The recalled product

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
Manufacturer
Rymed Technologies, LLC
Category
Medical Device — IV Connectors
Hazard
Affected units
46,600

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (5)

  • Catalog number RYM-7001 Lots: R01842
  • R01889
  • R01891
  • and R01897
  • Expire 03/2016.

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Rymed Technologies, LLC under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

Related recalls

Same manufacturer · Rymed Technologies, LLC

See all →

Same hazard · structural defect

See all →