ConvaTec, Inc recalls ConvaTec Active Life, One-Piece Drainable Pouch, 3/4-2 1/2 in., 19-64mm, REF 400598. For the management of stoma output following a…
impaired functionality of the release liner
Read the official notice →- Date
- 2022-11-02
- Country
- United States
- Brand
- ConvaTec
- Product
- ConvaTec Active Life, One-Piece Drainable Pouch, 3/4-2 1/2 in., 19-64mm, REF 400598. For the management of stoma output following a…
- Classification
- Class II
- Units
- US Nationwide distribution.
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 ConvaTec recalls
- 2024-04-17
USConvaTec, Inc recalls ConvaTec CarboFlex, 15cm x 20cm, 6 in. x 8 in., Order No. 403204, Odor Control Dressing, Sterile. Packaged 1 dressing/immediate package, 5…
The product does not meet sterility assurance level.
FDA · DeviceConvaTec, IncUS Nationwide distribution in the states of CA, MO, NM, PA, TX, and WA.Official notice →- 2024-03-27
- US
ConvaTec, Inc recalls Convatec EsteemBody Soft Convex, Drainable Pouch, Product codes (REF): a) 423643, b) 423658, c) 423659, d) 423664, e) 423666, f) 423645,…
Convatec Inc is conducting a Voluntary Medical Device Recall (removal) for specific lots of the EsteemBody Soft Convex, Drainable Pouch due to inconsistency in the strength of the filter weld.
FDA · DeviceConvaTec, IncWorldwide distribution - US Nationwide and the countries of Italy, UK.Official notice → - 2024-03-13
- US
ConvaTec, Inc recalls ConvaTec Natura Stomahesive Post-Operative / Surgical Ostomy System, REF 416938, 1 3/4 in. 45mm, Sterile.
The kit contains a flange that has a 45mm coupling ring, however, the pouch within the kit is for a 57mm coupling ring.
FDA · DeviceConvaTec, IncDistribution was made to AK, CA, FL, IL, IN, MI, NE, NJ, NY, OH, PA, and TX.…Official notice → - 2022-12-28
- US
ConvaTec, Inc recalls ConvaTec AQUACEL Foam Ag Adhesive, wound dressing advesive
ConvaTec are voluntarily recalling a batch of AQUACEL¿ Foam Ag Adhesive 10cm x 10cm (x 10 pack) due to the identification of visual contamination in the form of brown spots present on several dressings.
- 2022-06-01
- US
ConvaTec, Inc recalls SUR-FIT Natura S4S Durahesive Wafer 70MM (1X10PK) US. Each market unit contains 10 individual wafers.
Firm received 10 complaints of skin barrier delamination issues (e.g. flange lifts from wafer, skin barrier layers separate) or tape border rips/tears.
FDA · DeviceConvaTec, IncDistributed nationwide to NJ, PA, OH, CA, AL, MI, NY, TX, FL, NC, VA, LA, IL,…Official notice → - 2021-10-06
- US
ConvaTec, Inc recalls DuoDERM Control Gel Formula Border Dressings 15x15cm (1x5pk)
Primary packaging labeling may be incorrect.
FDA · DeviceConvaTec, IncDistribution in US and Canada US distribution in CA, FL, GA, IL, MD, MN, NC.…Official notice →
Other drugs & medical recalls in the United States
- 2022-11-02
- US
Intuitive Surgical, Inc. recalls da Vinci X (IS4200) and Xi (IS4000) systems, which consists of finished devices Surgeon Console (SSC), Patient Cart (PSCART), Vision…
Inadvertent energy delivery from surgical system instrument if 1) Force bipolar and bipolar instruments installed on system 2) Force bipolar connected to Force Triad generator, bipolar not connected to generator 3)…
FDA · DeviceIntuitive Surgical, Inc.US: MS, PA, WI, KY, TN, MI, FL, GA, NC, NV, LA, OH, IL, MO, IN, CA, AK, MD,…Official notice → - US
Angiodynamics, Inc. recalls Vortex MP Port Titanium Low Profile Implanted Port with 5F attached Silicone Catheter and Tray. Indicated for central venous placement…
Printed Instructions for Use (IFU) not shipped with device. The Instructions for Use contain the Warnings, Precautions, Contraindications, and Procedures for the Preparation, Implantation, and Post Operative Care of…
FDA · DeviceAngiodynamics, Inc.US Nationwide distribution in the states of AZ, CA, DC, IN, PA.Official notice → - US
Datascope Corporation recalls LINEAR 7.5Fr. 40cc IAB with Accessories (APA), Model No. 0684-00-0480-02. intra-aortic balloon catheter.
The balloon volume is incorrectly described as 34cc instead of 40cc on one of the three internal labels enclosed for hospital use. A labelling error may result in user confusion and/or delay in initiating therapy.…
FDA · DeviceDatascope CorporationNo US distribution. Foreign distribution to Argentina, Brazil, Canada, Chile,…Official notice → - US
Encore Medical, LP recalls EMPOWR Acetabular System, Liner, 10 deg Hooded, HXe+ 40H, REF: 942-01-40H. Orthopedic implant component.
Hip liner implant boxes may contain knee inserts and knee insert boxes may contain hip liner implants, which may lead to implants not being available for surgeries, which may cause delays in surgery.
FDA · DeviceEncore Medical, LPUS Nationwide distribution in the states of FL, IN, IL, KY, AZ, TX.Official notice → - US
MEDLINE INDUSTRIES, LP - Northfield recalls MEDLINE ADLT BLOOD CLUTURE COLLECT KIT, Reorder #: DYNDH1245
Adult Blood Culture Collect kit and Pre-Op Changing Bathing Kit contain an incorrect expiration date on a component with the kit. CHG Solution with the Pre-Op Changing Bathing Kit and Bactec bottle plastic both have an…
FDA · DeviceMEDLINE INDUSTRIES, LP - NorthfieldUS Nationwide distribution in the state of California.Official notice → - US
Siemens Medical Solutions USA, Inc recalls ARTIS pheno, Interventional fluoroscopic x-ray system, Model No. 10849000
Siemens has become aware of three potential software issues with ARTIS pheno systems with software version VE10B. This may lead to a hazardous situation for patients if treatment cannot be continued on the system and…
FDA · DeviceSiemens Medical Solutions USA, IncDomestic distribution nationwide. Foreign distribution worldwide.Official notice →