FDA recalls Regard IV Start Kit component over safety issue
Resource Optimization & Innovation LLC is recalling 3,570 Regard IV Start Kits due to a recalled component, the PDI Prevantics Swab. The affected kits were distributed to two consignees 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: This is an FDA Class II medical device recall with no reported illnesses or injuries. However, as a sterile IV access component intended for infection prevention, any recall represents a risk-of-harm scenario, warranting High severity classification.
Plain-English summary
The Regard IV Start Kit, specifically its PDI Prevantics Swab component, is being recalled by Resource Optimization & Innovation LLC. This product is used for preparing and dressing peripheral vein intravenous access sites.
The recall affects 3,570 kits that were distributed to two consignees in Missouri. Multiple lot numbers across three manufacturer item codes (303403REG, 303404REG, and 57931) are included in the recall.
The recalled product
- Product
- Regard IV Start Kit for preparing and/or dressing a peripheral vein intravenous access site
- Manufacturer
- Resource Optimization & Innovation LLC
- Category
- Medical Device — IV Access Kit
- Affected units
- 3,570
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)
- a. Manufacturer Item 303403REG
- UDI: 20326053105252 Batch/Lot Number 272394
- 272723
- 273243
- 274119
- 274222
- 275120
- 275700
- 276890
- 277198
- 277650
- 278195
- 278702
- 278984
- 279240
- 279592
- 281107
- 282148
- 282546
- 283355
Distribution
Distributed in 1 state:
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