Drugs & medicalClass II

Windstone Medical Packaging, Inc. recalls Prevantics swabs and/or swabsticks contained inside the following Aligned Medical Solutions convenience kits with Name/Pack…

Convenience kits contain one or more swab/swabstick drug products, manufactured by Professional Disposables International, that are subject to a drug recall due to uncertainty of the adequacy of the validation of the…

Read the official notice →
Date
2022-05-25
Country
United States
Brand
Windstone Medical Packaging
Product
Prevantics swabs and/or swabsticks contained inside the following Aligned Medical Solutions convenience kits with Name/Pack numbers: Ports…
Classification
Class II
Units
US: PA, WA, FL, GA
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 Details may be shortened or out of date; the official notice is the authoritative source.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 Windstone Medical Packaging recalls

  1. 2026-04-29
  2. US
    Drugs & medicalClass II

    Windstone Medical Packaging, Inc. recalls Custom Convenience Kits Pre Op Kit - NS, Part Number AMS14994

    The product correction was initiated because B Braun is issuing a voluntary Urgent Medical Device Correction for gravity IV administration sets as well as pump administration sets utilized with BBMI s Infusomat Space…

    FDA · DeviceWindstone Medical Packaging, Inc.US Nationwide distribution in the states of GA, OR, TN, and WA.Official notice →
  3. 2024-10-16
  4. US
    Drugs & medicalClass II

    Windstone Medical Packaging, Inc. recalls Aligned Medical Septo Pack REF AMS11480 that contains the Cardinal Health Salem Sump PVC tubes. Product packaged in a…

    Due to convenience kits containing a kit component that is under a recall action for improper use.

    FDA · DeviceWindstone Medical Packaging, Inc.U.S. Nationwide distribution in the states of CA, MO, OH, VA, and WY.Official notice →
  5. 2024-02-28
  6. US
    Drugs & medicalClass I

    Windstone Medical Packaging, Inc. recalls Aligned Medical Solutions, In House Ocular Pack, AMS12947, STERILEEO

    Sterility assurance for saline included in surgical kits cannot be guaranteed.

    FDA · DeviceWindstone Medical Packaging, Inc.US: FL, IL, CA OUS: NoneOfficial notice →
  7. 2023-05-31
  8. US
    Drugs & medicalClass II

    Windstone Medical Packaging, Inc. recalls Aligned Medical Solutions Hand Pack, REF: AmS4601E, containing P 2 Cover Light Handle Blue STE, Sterile EO

    Light handle covers may separate from the light handle (detach and fall off) during use, this could result in a procedure delay and/or impact the sterile field which could result in an injury to the patient

    FDA · DeviceWindstone Medical Packaging, Inc.US: MA OUS: NoneOfficial notice →
  9. 2023-01-11
  10. US
    Drugs & medicalClass II

    Windstone Medical Packaging, Inc. recalls Various Custom Surgical Instrument Disposable Kits: Part Numbers / Product Description 26000004M Custom Lasik Kit AMS10411A…

    Due to Customer Convenience Kits containing 3M Steri-Drape Surgical Drapes that have been recalled by 3M Healthcare.

    FDA · DeviceWindstone Medical Packaging, Inc.Worldwide distribution - U.S. Nationwide distribution in the states of AZ, CA,…Official notice →
  11. 2021-11-10
  12. US
    Drugs & medicalClass I

    Windstone Medical Packaging, Inc. recalls Monoject 0.9% Sodium Chloride, Flush Prefilled Syringe, 10 mL, REF: 8881570121 inside the following Aligned Medical Solutions…

    Monoject 0.9% Sodium Chloride Flush Syringe Manufactured by Cardinal Health and placed into kits. Potential for the plunger to draw back after air has been expelled and reintroduce air back into the syringe.

    FDA · DeviceWindstone Medical Packaging, Inc.FL and PAOfficial notice →
All 13 Windstone Medical Packaging recalls →

Other drugs & medical recalls in the United States

  1. 2022-05-25
  2. US
    Drugs & medicalClass II

    Luminex Corporation recalls VERIGENE Nucleic Acid Test Kit-BC-GN Extraction Tray - 9.73 mL, REF 20-009-021

    Higher than normal "No Call Internal Control failures" due to a missing reagent within a small subset of the extraction tray lot.

    FDA · DeviceLuminex CorporationUSOfficial notice →
  3. US
    Drugs & medicalClass II

    CooperSurgical, Inc. recalls VITRIGUARD, CARRIER, CLEAR; Model. No. 43782001 The VitriGuard device is a cryopreservation storage device composed of a stick and cap.

    Products in this lot may have compromised barrier seals, introducing a risk to sterility.

    FDA · DeviceCooperSurgical, Inc.Domestic distribution to AZ, CA, FL, IL, MI, MO, NY, OR, TX, and WV. No…Official notice →
  4. US
    Drugs & medicalClass II

    Heartware, Inc. recalls HeartWare Ventricular Assist Device (HVAD) System Controller, Model Number 1407DE Kit

    Finnish and Turkish translation errors in HVAD controller and monitor displays as will as Instructions for Use, Patient Manual, and Emergency Responder Guide for the HeartWare Ventricular Assist Device (HVAD) system.

    FDA · DeviceHeartware, Inc.Finland and TurkeyOfficial notice →
  5. US
    Drugs & medicalClass II

    Clinician's Choice Dental Products Inc. recalls Affinity Hydroactive Impression Material Heavy Body Regular Set 12PK- A vinyl poly siloxane material used to create, via…

    Wrong compression material - Template Ultra Quick matrix Material was packaged instead of the Heavy Body viscosity as indicated on the outer packaging of the 12PK

    FDA · DeviceClinician's Choice Dental Products Inc.Distributed in SC.Official notice →
  6. US
    Drugs & medicalClass II

    Smith & Nephew Inc recalls LEGION NARROW PS OXIN SZ 6N RT and JRNY II BCS FEMORAL OXIN LT SZ 5

    It was reported that a JOURNEY II BCS Femoral OXIN LT SZ5 was in a box labelled as a LEGION NARROW PS OXIN SZ 6N RT.

    FDA · DeviceSmith & Nephew IncWorldwide distribution - US Nationwide distribution in the states of CT, NC,…Official notice →
  7. US
    Drugs & medicalClass III

    Randox Laboratories Ltd. recalls CK MB Calibrator, Catalogue Number CK2393

    Randox have realigned CK-MB Calibrator, CK2393, lot number 4410CK. Calibrating with the new value will cause a positive shift of approximately 6% with both Quality Controls and Patient Samples.

    FDA · DeviceRandox Laboratories Ltd.Domestic distribution to WV and PR. International distribution to Bangladesh,…Official notice →
See all drugs & medical recalls →