Regard Custom Procedure Kits with BD Luer Lok Access Devices Recalled
ROi CPS LLC is recalling 1,750 Regard Custom Procedure Kits containing BD Luer Lok Access Devices distributed nationwide in Missouri.
The agency’s classification
FDA (Devices): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
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 2/5 (Moderate).
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: This recall is classified as FDA Class III, the lowest regulatory classification. No illnesses, injuries, or adverse events are reported in the source material. Per the severity rubric, FDA Class III recalls are typically assigned scores of 1 or 2; a score of 2 (Moderate) is applied because this is a medical device recall, even without a specified hazard.
Plain-English summary
ROi CPS LLC is recalling 1,750 Regard Custom Procedure Kits containing BD Luer Lok Access Devices under FDA Recall No. Z-0837-2022, classified as Class III. These kits were distributed nationwide in Missouri.
Affected products include Item No. 830110 (Lots 89222 and 87572, expiring March 12, 2022) and Item No. 830110002 (Lots 91226, 90641, and 90446, expiring May 12, 2022). The recalled devices were packaged in convenience kits for clinical use.
Healthcare facilities with affected lots should verify their inventory against the lot numbers listed and contact ROi CPS LLC or the FDA with questions regarding the recall.
The recalled product
- Product
- Regard Custom Procedure Kits containing BD Luer Lok Access Devices
- Manufacturer
- ROi CPS LLC
- Category
- Medical Device — Procedure Kit
- Affected units
- 1,750
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)
- IV START LABOR BIRTH convenience kits: 1) Item No. 830110
- Lots 89222 and 87572 (exp. MAR/12/2022 2) Item No. 830110002
- Lots 91226
- 90641
- and 90446 (exp. MAY/12/2022)
Distribution
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