Riverpoint Medical Recalls 18G Brachy Grids Due to Packaging Integrity
Riverpoint Medical is recalling 3,234 sterile 18G Brachy Grids because the integrity of the sterile packaging is potentially compromised.
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 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: The recall is classified as FDA Class II. The hazard is a potential compromise in sterile packaging integrity, which is a theoretical risk of contamination without reported injuries or illnesses, fitting the criteria for a moderate severity score.
Plain-English summary
Riverpoint Medical, LLC is recalling 3,234 units of the 18G Brachy Grid, B&K style, REF RPG-18. The devices are sterile and require a prescription. The recall was initiated because the integrity of the sterile grid packaging is potentially compromised.
The affected devices were distributed to Illinois, Florida, Texas, and Washington. There was no foreign, military, or government distribution. The recall includes specific lot numbers and UDI number 00812444028638.
Healthcare providers and facilities should stop using the affected devices and contact Riverpoint Medical for further instructions.
The recalled product
- Product
- Riverpoint Medical 18G Brachy Grid, B&K style, REF RPG-18, Sterile, Rx. The firm name on the label is Riverpoint Medical, LLC, Portland, OR.
- Manufacturer
- Riverpoint Medical, LLC
- Affected units
- 3,234
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 (15)
- Lot numbers 16032422
- 16051814
- 16051815
- 16052425
- 17042430
- 17050936
- 17052532
- 17061214
- 17121823
- 17122820
- 18040922
- 18061816
- 18101521
- and 18120705
- UDI number 00812444028638.
Distribution
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