Sage Products Inc recalls stryker Sage PrimaFit External Urine Management System for the Female Anatomy
A small percentage of devices in three lots of product may contain a tape with a natural rubber latex adhesive which is not declared on the label
Read the official notice →- Date
- 2023-11-29
- Country
- United States
- Brand
- Sage Products
- Product
- stryker Sage PrimaFit External Urine Management System for the Female Anatomy
- Classification
- Class II
- Units
- US and Canada
- Category
- Drugs & medical
- Source
- FDA · Device
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Sage Products recalls
- 2026-09-09
US
Other drugs & medical recalls in the United States
- 2023-11-29
- US
SunMed Holdings, LLC recalls Medline manual resuscitators with integrated manometer, multiple accessory configurations to include: 1. Adult Resuscitator REF #s:…
A backwards leak present in the integrated manometer of the patient valve allows for CO2 rebreathing.
FDA · DeviceSunMed Holdings, LLCUS Nationwide distribution including in the states of AR, AZ, CA¿CO, CT, FL,…Official notice → - US
Avanos Medical, Inc. recalls AVANOS BALLARD Closed Suction System for Adults, 14 Fr, DSE, MDI, Product code 221038, provide suction on patients on mechanical ventilation
Certain lots of BALLARD Closed Suction System for Adults, 14 Fr, DSE, MDI were labeled as not being made with Di(2-ethylhexyl) phthalate (DEHP); however, Avanos has determined that the tubing components of the product…
- US
Instrumentation Laboratory recalls GEM Premier 3000 PAK - pH, pCO2, pO2, Hct, Na+, K+, Ca++, Part Numbers 00024307507, 00024315007, 00024330007, 00024345007, 00024360007
Internal testing identified that the GEM Premier PAKs (cartridges) may exhibit an over-recovery (i.e., positive bias) of pO2 results in the low range (at pO2 levels less than 60 mmHg) that are outside of labeled…
- US
Medtronic Neuromodulation recalls Model 97745 Controller used with Models 97715 and 97716 Intellis Neurostimulators
Units distributed in Korea and Turkey that did not have the correct firmware installed to support the user interface in the local language.
FDA · DeviceMedtronic NeuromodulationInternational distribution to the countries of S. Korea and Turkey.Official notice → - US
BioFire Diagnostics, LLC recalls FilmArray TORCH REF HTFA-ASY-0104. HTFA-ASY-0104 is the BIOFIRE TORCH Base which includes barcode scanner, touch screen computer and USB…
Due to an increased risk of degradation of the power entry switch resulting from arcing inside of the power switch that may result in carbon build-up on the switch contacts. The carbon build-up may lead to excess…
FDA · DeviceBioFire Diagnostics, LLCWorldwide - U.S. Nationwide distribution including in the states of AK, AL,…Official notice → - US
Roche Diagnostics Operations, Inc. recalls Tina-quant D-Dimer Test System, Fibrinogen/Fibrin Degradation Products Assay, Material Numbers 03001245322 - (cobas c 311,…
Elevated results were detected with Li-heparin plasma samples when compared to citrated plasma samples.