Stradis Medical, LLC dba Stradis Healthcare recalls Coryell Memorial Hosp Total, Joint Pack - Surgical Kit
The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit.
Read the official notice →- Date
- 2022-04-13
- Country
- United States
- Brand
- Stradis Medical, LLC dba Stradis Healthcare
- Product
- Coryell Memorial Hosp Total, Joint Pack - Surgical Kit
- Classification
- Class II
- Units
- US Nationwide distribution in the states of IN, TX, and PA.
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Stradis Medical, LLC dba Stradis Healthcare recalls
- 2022-12-21
USStradis Medical, LLC dba Stradis Healthcare recalls HENRY SCHEIN, Vas Reversal Pack, Item No.888-2549,
Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in the sterility of the kit.
FDA · DeviceStradis Medical, LLC dba Stradis HealthcareUS nationwide distribution, and Canada.Official notice →- 2022-08-24
- US
Stradis Medical, LLC dba Stradis Healthcare recalls NARMD MEDICAL DEPOT Forceps - Kelly Straight 5.5"; Part Number: ZZ-0700
The sterile barrier may be compromised.
FDA · DeviceStradis Medical, LLC dba Stradis HealthcareUS Nationwide distribution in the state of SC.Official notice → - 2021-12-29
- US
Stradis Medical, LLC dba Stradis Healthcare recalls Custom Assemblies, Inc., Single Spike Tumescent Set w/o Chamber, Reorder Number CMS-1212NS Bulk
This recall has been initiated to address bulk packed, non-sterile Intravascular Administration Sets that were erroneously distributed to fill orders for the sterile version of the same Intravascular Administration Set.
FDA · DeviceStradis Medical, LLC dba Stradis HealthcareNJ, MI, MA, NY, TX, CO, NC, CT, OR, OHOfficial notice → - 2021-10-27
- US
Stradis Medical, LLC dba Stradis Healthcare recalls Foundation Kit
Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.
FDA · DeviceStradis Medical, LLC dba Stradis HealthcareDistributed nationwide to VA, SC, CA, PA, MA, FL, TN, NJ, GA, AZ, IL, OH, OK,…Official notice →
Other drugs & medical recalls in the United States
- 2022-04-13
- US
Philips North America Llc recalls Philips Allura (Model Numbers 722010, 722012, 722026, 722027, 722028, 722029, 722035) and Philips Azurion (Model Numbers 722063,…
Due to a software defect, the Philips StentBoost Live R2.0 might not process X-ray images of the current run and instead show an image processed in a previous run. The image shown could be from the same patient or from…
- US
Draeger Medical, Inc. recalls Evita V500 Ventilator with Software 2.51.01 and Lower - intended for the ventilation of adult, pediatric and neonatal patients Catalog…
Cybersecurity Improvement Action-not equipped against potential cyber security threats
- US
Shimadzu Medical Systems recalls MODEL: X-RAY TV SYSSTEM SONIALVISION safire17
It was found that the irradiated x-ray may exceed the xray radiation dose rate specified in CFR 1020.32 in some specific case of fluoroscopic mode due to inadequate adjusting criteria in installation.
FDA · DeviceShimadzu Medical SystemsU.S.: AK, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MI, MN,…Official notice → - US
Remote Diagnostic Technologies Ltd. recalls Tempus LS, Type DGE1, CAT 00-3010, REF 3.940590, Software version 1.3.5, UDI: (01)07613365001693
Distribution of Defibrillators that are not approved or cleared for distribution US Market.
FDA · DeviceRemote Diagnostic Technologies Ltd.US Nationwide distribution in the states of IL and KS.Official notice → - US
GE Healthcare, LLC recalls Signa 1.5T TwinSpeed Magnetic Resonance Imaging System
There is potential for the images to be flipped left to right.
FDA · DeviceGE Healthcare, LLCWorldwide Distribution. US nationwide, Argentina, Australia, Azerbaijan,…Official notice → - US
SA3, LLC recalls Silatrix Oral Gel Polymerized Sucralfate Gel 10% (1 gm/10 gm
Due to failure of microbial testing for total aerobic microbial count (TAMC).