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FDA (Device enforcement)Recalled 2022-02-28closedclass ii

Resource Optimization & Innovation LLC: Regard IV Start Kit for preparing and/or dressing a peripheral vein intravenous access site

Is my product affected?

Regard IV Start Kit for preparing and/or dressing a peripheral vein intravenous access site

  • UPC 20326053105252
  • UPC 20326053105269

Check against the official notice below — it lists the full affected range.

What happened

Resource Optimization & Innovation LLC is recalling 3,570 Regard IV Start Kits used for preparing and dressing peripheral vein intravenous access sites. The recall affects kits distributed to two consignees in Missouri. A component of the kit, the PDI Prevantics Swab, was recalled, though the specific reason for the swab's recall is not detailed in this record.

The affected kits are identified by three manufacturer items (303403REG, 303404REG, and 57931) with multiple associated lot numbers. The source document does not specify a remedy or any actions affected consumers should take.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

A kit component, the PDI Prevantics Swab, was recalled.

Details from the source

Reason for recall: A kit component, the PDI Prevantics Swab, was recalled. Distribution: US distribution to two consignees located in Missouri Quantity: 3,570 kits Lot/code info: 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, 283758, 283985, 284757, 285260, 286471, 287025, 287757, 287995, 288331, 288535, 289809, 290876, 291283, 292384 b. Manufacturer Item 303404REG; UDI: 20326053105269 Batch/Lot Number 272920, 273244, 273589, 273982, 275005, 275462, 276185, 276898, 277665, 279246, 279597, 283768, 284492, 285144, 285594, 286503, 287537, 288105, 281116, 281378, 281951, 282860, 288553, 288990, 289829, 290601 c. Manufacturer Item 57931 Batch/Lot Number 273102, 275515, 276078, 276342, 277476, 279353, 281577, 282456, 283231, 283246, 284704, 289997, 288248

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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