Z-0795-2020Class II

Riverpoint Medical 18G Brachy Grid, B&K style, REF RPG-18, Sterile, Rx. The firm name on the label is...

Name: Z-0795-2020 Riverpoint Medical 18G Brachy Grid, B&K style, REF RPG-18, Sterile, Rx. The firm name on the label is...
Creator: Riverpoint Medical, LLC
Published: 2019-02-08
License: https://open.fda.gov/license/

Riverpoint Medical, LLC / initiated 2019-02-08 / Terminated / root cause: packaging

FDA source

Riverpoint Medical, LLC began a recall of 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 on 2019-02-08. FDA classified it as Class II and gives the reason as "The integrity of the sterile grid packaging is potentially compromised". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0795-2020
Classification: Class II
Status: Terminated
Initiated: 2019-02-08
Posted: 2020-01-10
Terminated: 2021-04-28
Recalling firm: Riverpoint Medical, LLC
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.
Product code: IWJ System, Applicator, Radionuclide, Manual
Reason for recall: The integrity of the sterile grid packaging is potentially compromised.
Root cause tag: packaging
FDA root cause: Packaging
Action: Recall notifications dated 2/8/2019 were issued via email and overnight mail on 2/8/2019.
Quantity in commerce: 3,234 devices
Distribution: Distribution was made to IL, FL, TX, and WA. There was no foreign/military/government distribution.
Product codes and lots: Lot numbers 16032422, 16051814, 16051815, 16052425, 17042430, 17050936, 17052532, 17061214, 17121823, 17122820, 18040922, 18061816, 18101521, and 18120705; UDI number 00812444028638.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0795-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0795-2020	Class II	Terminated	Voluntary: Firm initiated	2020-01-22	2020-01-10

Product code IWJ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)