The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1005-2022·Announced 2022-05-04

IV Start Kit Convenience Kits Recalled for Inadequate Test Method Validation

ROi CPS LLC is recalling 1,501 convenience kits containing regard IV Start Kits due to inadequate validation of manufacturing test methods. Products were distributed in Missouri.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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: FDA Class II recall of an invasive medical device with inadequate validation of manufacturing test methods, representing a risk-of-harm product where no patient injuries have been reported to date.

Plain-English summary

ROi CPS LLC has recalled 1,501 convenience kits containing regard IV Start Kits due to potential inadequacy of the validation of test methods used in manufacturing. The recall affects two models: regard Clinical Packaging Solutions Item 830015013 (LD00200M) and Item 830084003 (LD00866C), both intended for vaginal delivery. Multiple lot numbers of both items are included, with expiration dates ranging from March 2022 through January 2023.

The affected products were distributed in Missouri. Consumers and healthcare providers who have received these kits should stop using them and contact their healthcare provider or ROi CPS LLC. Specific lot numbers and expiration dates are available from the FDA recall database for identification of affected units.

No patient injuries or illnesses have been reported in connection with this recall.

The recalled product

Product
Convenience kits containing regard IV Start Kits: (1) regard Clinical Packaging Solutions, Item Number: 830015013, LD00200M - Vag Delivery Mother; and (2) regard Clinical Packaging Solutions, Item Number: 830084003, LD00866C - Vag Delivery Mother.
Manufacturer
ROi CPS LLC
Category
Medical Device — IV Administration
Hazard
Affected units
1,501

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 (20)

  • (1) Item Number: 830015013 - Lot numbers 87230M
  • exp. 5/31/2022
  • 87954M
  • 88285M
  • 88999M
  • exp. 6/30/2022
  • 89494
  • 89985
  • 90866
  • and 91603
  • exp. 5/31/2023
  • and (2) Item 830084003 - Lot numbers 86155C
  • exp. 3/31/2022
  • 84799C
  • 86735C. exp. 3/31/2022
  • 87269C
  • exp. 7/31/2022
  • 87871C
  • 88564C
  • exp. 1/31/2023

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 3 recalled by ROi CPS 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 3 products in this recall →

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