Drugs & medicalClass I

Deroyal Industries, Inc. Lafollette recalls DeRoyal Procedure Packs containing Smiths Medical NORMOFLO Irrigation Warming Set

DeRoyal manufactured procedure packs containing a Smiths Medical NORMOFLO Irrigation Warming System which is recalled due to the potential for aluminum ions leaching into warming fluids.

Read the official notice →
Date
2021-10-06
Country
United States
Brand
Deroyal Industries, Inc. Lafollette
Product
DeRoyal Procedure Packs containing Smiths Medical NORMOFLO Irrigation Warming Set
Classification
Class I
Units
US distribution in Florida and South Carolina.
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 Details may be shortened or out of date; the official notice is the authoritative source.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

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. 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.

Other drugs & medical recalls in the United States

  1. 2021-10-06
  2. US
    Drugs & medicalClass II

    B. Braun Medical, Inc. recalls PUMP SET, 15 DR, 3 CARESITE, 127 in.single-use for use with the Outlook Safety Infusion System and/or Horizon NXT Pump for infusion of…

    Leakage of the pump set within the cassette portion of the pump sets, potential for delays in administration of medications, under-delivery or incomplete dosing and bloodstream infections.

    FDA · DeviceB. Braun Medical, Inc.Worldwide distribution - US Nationwide distribution and the country of Canada.Official notice →
  3. US
    Drugs & medicalClass II

    Vascutek, Ltd. recalls The Instructions for Use (IFU) for: Gelsoft Plus Bifurcate, Gelsoft Plus Ax-Fem, GelsoftPlus ERS Ax-Fem, Gelweave Straight, Gelweave…

    The devices contained the IFU for distribution to ROW (rest of world) consignees rather than U.S. consignees.

    FDA · DeviceVascutek, Ltd.Distribution was made to PR and Guam.Official notice →
  4. US
    Drugs & medicalClass I

    Accelerated Care Plus Corporation recalls Omnisound Gel, 250 ml bottle and 5 L container; and EcoGel 200, 250 ml bottle; Manufactured by Eco-Med. For use in ultrasound…

    Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021, FDA published a Letter to Health Care Providers to further address this issue:…

    FDA · DeviceAccelerated Care Plus CorporationUS nationwide distribution.Official notice →
  5. US
    Drugs & medicalClass II

    Greiner Bio-One North America, Inc. recalls VACUETTE TUBE 6 ml K2E K2EDTA 13x100 pink cap-pink ring, non-ridged

    Blood collection tubes may experience a clotting issue.

    FDA · DeviceGreiner Bio-One North America, Inc.Distribution was made to AL, AZ, CO, CT, FL, IL, MA, MD, MI, MO, NC, NM, PA,…Official notice →
  6. US
    Drugs & medicalClass II

    New Vitalis Pharmacy LLC dba New Vitalis Pharmacy recalls Testosterone Cypionate Testosterone Propionate, 180mg/mL, 20mg/mL, 1 mL vial, Rx only, New Vitalis Pharmacy…

    Lack of Assurance of Sterility

    FDA · DrugNew Vitalis Pharmacy LLC dba New Vitalis PharmacyNationwide within the United StatesOfficial notice →
  7. US
    Drugs & medicalClass II

    SigmaPharm Laboratories LLC recalls Sodium Phenylbutyrate Powder, 250 Grams, Rx Only, packaged in 500 cc HDPE bottles and 53 mm CRC caps packed in a carton and then in…

    Failed Impurities/Degradation Specifications; Out of Specification impurity results obtained during routine testing.

    FDA · DrugSigmaPharm Laboratories LLCNationwideOfficial notice →
See all drugs & medical recalls →