The Recall Desk
ModerateFDA (Devices)·Z-1006-2022·Announced 2022-05-04

IV Start Kit convenience kits recalled for manufacturing validation defect

ROi CPS LLC recalled 950 IV Start Kit convenience kits due to potential inadequacy in manufacturing test method validation. No injuries reported.

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 injuries, illnesses, or hospitalizations. The issue is a manufacturing process validation defect rather than an active product safety hazard.

Plain-English summary

ROi CPS LLC is recalling 950 convenience kits containing regard IV Start Kits (Item Number 830110002, IV01121B - IV Start Labor Birth). The affected kits were distributed nationwide in Missouri.

The recall was issued due to potential inadequacy in the validation of test methods used during manufacturing. This represents a manufacturing quality control issue in how the manufacturer validated its testing processes.

The affected lot numbers are 89889, 90446, and 90641 (all with expiration date May 12, 2022). No injuries or illnesses have been reported to date. Consumers with affected kits should contact ROi CPS LLC or their healthcare provider for further instructions.

The recalled product

Product
Convenience kits containing regard IV Start Kits: regard Clinical Packaging Solutions, Item Number: 830110002, IV01121B - IV Start Labor Birth.
Manufacturer
ROi CPS LLC
Category
Medical Device — IV Administration Kit
Hazard
  • manufacturing-validation

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)

  • Lot numbers 89889
  • exp. 5/12/2022
  • 90446
  • and 90641
  • exp. 5/12/2022.

Distribution

Distributed nationwide across the United States.

Related recalls

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