Drugs & medicalClass II

ROi CPS LLC recalls regard Clinical Packaging Solutions Item Number 830096005, OB01054E - Newborn Kit, containing 2 25GA x .625IN needles.

The kit contains a non-sterile needle.

Read the official notice →
Date
2021-12-29
Country
United States
Brand
ROi CPS
Product
regard Clinical Packaging Solutions Item Number 830096005, OB01054E - Newborn Kit, containing 2 25GA x .625IN needles.
Classification
Class II
Units
Distribution was made to Missouri. There was no foreign/military/government…
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 Details may be shortened or out of date; the official notice is the authoritative source.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.

More ROi CPS recalls

  1. 2022-05-18
  2. US
    Drugs & medicalClass II

    ROi CPS LLC recalls Regard brand CABG Pack A and B - Spartanburg

    Kits were packed into shipping boxes incorrectly.

    FDA · DeviceROi CPS LLCRecall impacted one domestic consignee in NCOfficial notice →
  3. 2022-05-04
  4. US
    Drugs & medicalClass II

    ROi CPS LLC recalls Convenience kits containing regard IV Start Kits: (1) regard Clinical Packaging Solutions, Item Number: 830015013, LD00200M - Vag Delivery…

    A drug kit component was recalled by its manufacturer due to the potential for inadequacy of the validation of test methods used in its manufacture.

    FDA · DeviceROi CPS LLCUS Nationwide distribution in the state of Missouri.Official notice →
  5. 2022-04-06
  6. US
    Drugs & medicalClass III

    ROi CPS LLC recalls Regard Custom Procedure Kits containing BD Luer Lok Access Devices

    Recalled devices were packaged in convenience kits.

    FDA · DeviceROi CPS LLCUS Nationwide distribution in the state of Missouri.Official notice →
  7. 2022-03-09
  8. US
    Drugs & medicalClass II

    ROi CPS LLC recalls Regard, TOTAL HIP - SPRINGFIELD, Item No. 8800297010, Case Quantity: 2, Sterile

    Products are mislabeled with the incorrect product identification on individual kit labeling.

    FDA · DeviceROi CPS LLCMissouriOfficial notice →
  9. 2022-01-19
  10. US
    Drugs & medicalClass II

    ROi CPS LLC recalls Regard, T AND A - Rogers, sterilized convenience kits

    Kits lacks rubber latex warning label.

    FDA · DeviceROi CPS LLCUS Nationwide distribution in the state of MO.Official notice →
  11. 2021-11-24
  12. US
    Drugs & medicalClass II

    ROi CPS LLC recalls REGARD Vitrectomy Tray

    Povidone-Iodine swabstick manufactured by PDI, Inc. recalled due to Out of Specifications was used as a component in some of the ROI CPS, LLC products.

    FDA · DeviceROi CPS LLCUS Nationwide in the states of FL, LA and MO.Official notice →
All 20 ROi CPS recalls →

Other drugs & medical recalls in the United States

  1. 2021-12-29
  2. US
    Drugs & medicalClass II

    Cook Inc. recalls Skinny Needle with Chiba Tip. RPN 090010, 090010-ET; GPN G14254, G15290. Rigid needle available with EchoTip to provide enhanced…

    Specific lots may contain black debris on the exterior of the inner stylet and/or on the interior of the outer cannula. Local inflammatory reactions may occur if an affected product is used.

    FDA · DeviceCook Inc.Worldwide distribution - US Nationwide distribution in the states of AL, CA,…Official notice →
  3. US
    Drugs & medicalClass II

    Coloplast Manufacturing US, LLC recalls Torosa Saline-Filled Testicular Prosthesis (Size Small)

    Product is mislabeled for size.

    FDA · DeviceColoplast Manufacturing US, LLCWorldwide distribution - US Nationwide distribution and the country of Canada.Official notice →
  4. US
    Drugs & medicalClass II

    Leica Microsystems, Inc. recalls Leica Microsystems M220 F12 Microscope Systems

    In May 2021, Leica Microsystems received one (1) complaint pertaining to the M220 F12 Surgical Microscope system. There was no patient injury reported for this complaint. However, the identified defect carries some…

    FDA · DeviceLeica Microsystems, Inc.Worldwide distribution - US Nationwide distribution in the states of CA, DC,…Official notice →
  5. US
    Drugs & medicalClass II

    Beaver Visitec International, Inc. recalls Malosa Core SMILE Pack 1-Medical Refractive Kit intended to be used to aid in cataract, corneal, or refractive surgery. Part…

    Kit packaging may have small holes compromising product sterility

    FDA · DeviceBeaver Visitec International, Inc.CA, CO, LA, MA, MD, ND, PA, TN, UTOfficial notice →
  6. US
    Drugs & medicalClass II

    MEDLINE INDUSTRIES, LP - Northfield recalls Stanbio TDM/B-Hydroxybutyrate Tri-Level Controls, Ref. No. 2460-605

    Affected product was shipped from the warehouse at room temperature instead of the required refrigerated environment.

    FDA · DeviceMEDLINE INDUSTRIES, LP - NorthfieldUS Nationwide distribution in the states of IL, OH, MS, and PA.Official notice →
  7. US
    Drugs & medicalClass II

    Maquet Cardiovascular, LLC recalls Hemashield Gold Knitted Bifurcated, 18 mm x 9 mm; reference number M002020851890

    There is a probable mislabeling of product. A Hemashield Platinum Woven Double Velour Bifurcated Vasuclar Graft, SN 1259735369, 24 mm x 12 mm, REF Number M00202166241P0 is likely packaged inside of the carton instead…

    FDA · DeviceMaquet Cardiovascular, LLCUS Nationwide distribution in the states of IL and NC.Official notice →
See all drugs & medical recalls →