The Recall Desk
HighFDA (Devices)·Z-0675-2016·Announced 2016-01-27

Rymed InVision-Plus IV Connectors Recalled for Cracking Risk

Rymed Technologies is recalling InVision-Plus 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 to patients, but no injuries or illnesses have been reported in the source text.

Plain-English summary

Rymed Technologies, LLC is recalling approximately 496,400 units of InVision-Plus and InVision-Plus Junior Needleless IV Connectors. These disposable, single-use products are intended for intravenous and blood administration sets to eliminate needle-stick injuries.

The recall was initiated due to a potential for the female luer component of the InVision-Plus IV connector to crack during use. The affected products were distributed nationwide in the United States.

Healthcare facilities and distributors should stop using the affected lots and contact Rymed Technologies for further instructions. The specific catalog numbers and lot numbers are listed in the official recall documentation.

The recalled product

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.
Manufacturer
Rymed Technologies, LLC
Category
Medical Device — IV Connectors
Hazard
Affected units
496,400

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 (19)

  • 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

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

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Same hazard · structural defect

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