The Recall Desk
ModerateFDA (Devices)·Z-1004-2022·Announced 2022-05-04

IV Start Kit Convenience Kits Recalled for Manufacturing Test Validation Issue

ROi CPS LLC is recalling 290 convenience kits containing IV Start Kits due to potential inadequacy in the validation of test methods used during manufacturing. Distribution was in Missouri.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: FDA Class II recall with no reported illnesses or injuries. The hazard is a manufacturing validation concern characterized as precautionary without documented patient harm.

Plain-English summary

ROi CPS LLC has recalled 290 convenience kits containing regard IV Start Kits due to a potential issue with the manufacturing process.

The recall was initiated because of potential inadequacy in the validation of the test methods used in the manufacture of the kits. Specifically, affected items include Item Number 830014015 (Lot 87229O, expiring 5/31/2022) and Item Number 830014016 (multiple lots, expiring between 5/31/2022 and 5/31/2023).

The recalled kits were distributed nationwide in Missouri. Healthcare providers and patients who have these kits should contact their supplier or ROi CPS LLC for recall information and replacement options.

No illnesses or injuries related to this recall have been reported to the FDA.

The recalled product

Product
Convenience kits containing regard IV Start Kits: (1) regard Clinical Packaging Solutions, Item Number: 830014015, LD00199O - C Section Mother; and (2) regard Clinical Packaging Solutions, Item Number: 830014016, LD00199P - C Section Mother.
Manufacturer
ROi CPS LLC
Category
Medical Device — IV Administration
Hazard
Affected units
290

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 (16)

  • (1) Item #830014015 - Lot number 87229O
  • exp. 5/31/2022 (2) Item #830014016 - Lot numbers 87952P
  • exp. 5/31/2022
  • 88219P
  • exp 6/30/2022
  • 89163
  • exp. 6/30/2022
  • 89430
  • 89926
  • 90372
  • exp
  • 6/30/2022
  • 91054
  • exp. 12/31/2022
  • and 91443
  • exp. 5/31/2023.

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 →

Related recalls

Same manufacturer · ROi CPS LLC

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Same hazard · manufacturing validation

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