Stryker Instruments Div. of Stryker Corporation recalls Triton Canister System (finished part numbers FG 12009, for 3L canisters, and FG 12019 for 2L canisters)…
Some Canister Scanning Labels used to calibrate the Triton Canister System have a color variance. Based on a comprehensive analysis, blood loss estimates obtained using these Canister Scanning Labels may result in…
Read the official notice →- Date
- 2022-07-27
- Country
- United States
- Brand
- Stryker Instruments Div. of Stryker
- Product
- Triton Canister System (finished part numbers FG 12009, for 3L canisters, and FG 12019 for 2L canisters) Scanning Label (component part…
- Classification
- Class II
- Units
- US Nationwide
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Stryker Instruments Div. of Stryker recalls
- 2022-07-27
USStryker Instruments Div. of Stryker Corporation recalls SurgiCount+ System Application, Software Version 2.0.17, Catalog Number 0694-002-090. Used for counting,…
When scanning sponges out after a surgical procedure, an error may allow for a duplicate sponge to be counted without the prompt to make a case note and allowing the case to close. The software update will prevent the…
FDA · DeviceStryker Instruments Div. of Stryker CorporationThe products were distributed to the following US states: KS and ME.Official notice →- US
Stryker Instruments Div. of Stryker Corporation recalls Triton Sponge System (Software), GAUS-3, Software Versions 4.6.5, 4.8.7, 4.9.6
Gauss Surgical is updating the Instructions for Use (IFU) for our Triton Sponge System in order to clarify proper technique for handling sponges and the calibration placard.
Other drugs & medical recalls in the United States
- 2022-07-27
- US
Aesculap Implant Systems LLC recalls RIGHT CORONAL BENDER, TEK1940. Instrument used during spinal surgery.
Customized coronal rod benders may deform the implant when used with the spinal system devices.
- US
Xstrahl Limited recalls X80 RADiant Photoelectric Therapy System
There is a potential compatibility issue with the systems and replacement treatment applicators.
- US
RAYSEARCH LABORATORIES AB recalls RayStation 9B SP1. For radiation treatment planning.
An issue with propagation of treatment course information from RayStation with RayTreat to RayCare has been identified. During some workflows, information may not be propagated to RayCare.
FDA · DeviceRAYSEARCH LABORATORIES ABWorldwide distribution - US Nationwide distribution in the state of TN and the…Official notice → - US
Surgical Innovations Ltd recalls YelloPort Elite Universal Seal. For use in laparoscopic procedures.
There is the potential that YelloPort Elite Universal Seals packaging may contain small holes which may affect the sterility of the product.
FDA · DeviceSurgical Innovations LtdWorldwide distribution - US Nationwide distribution in the states of FL, IN,…Official notice → - US
Stryker Instruments Div. of Stryker Corporation recalls Triton Sponge System (Software), GAUS-3, Software Versions 4.6.5, 4.8.7, 4.9.6
Gauss Surgical is updating the Instructions for Use (IFU) for our Triton Sponge System in order to clarify proper technique for handling sponges and the calibration placard.
- US
Synapse Biomedical Inc recalls NeuRx Diaphragm Pacing System (NeuRx DPS), Affected part numbers: Part # Part Name 20-0035 NeuRx DPS System Kit 20-0036 NeuRx Diaphragm…
Firm has revised labeling to consistently call out storage conditions and revised the instructions for use to clarify that the temperature range symbol is intended to indicate storage conditions (versus transport…
FDA · DeviceSynapse Biomedical IncDomestic distribution to AL CA CO FL GA IL MA MI MN NC NJ NY OH OK OR PA SC TX…Official notice →