FDA daily for Monday, April 28, 2025
In this issue: 11 approvals, 14 device recalls, 11 device decisions and 90 label changes. 2 items touch categories MedGrid carries, and they come first.
For MedGrid's categories
Items in this issue that name a product category sold on MedGrid. Each links to its full FDA record; the chip opens that category's federal and state rules.
- Baby Mantra Diaper Cream
ZINC OXIDE 10% · Renu Laboratories, LLC · TOPICAL
- REPAIRWEAR UPLIFTING FIRMING BROAD SPECTRUM SPF 15 DRY
OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE · CLINIQUE LABORATORIES LLC · TOPICAL
Drug and biologic approvals
FDA date:On Mon, Apr 21 FDA approved 2 new applications (1 brand or biologic, 1 generic) and 9 supplements to existing ones.
- IMATINIB MESYLATE
CSPC OUYI · IMATINIB MESYLATE
- CARBON DIOXIDE, USP
MITCHELL WEDLING SUPPLY · CARBON DIOXIDE
Device recalls
FDA date:FDA posted 14 device recalls from 6 firms on Mon, Apr 21.
- Zenition 50. Product Code 718096. The devices are used for radiological guidance and visualization during diagnostic, interventional and su…
Philips North America Llc · A wireless foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation.
- Zenition 70. Product Code 718133. The devices are used for radiological guidance and visualization during diagnostic, interventional and su…
Philips North America Llc · A wireless foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation.
- Veradius Unity. Product Code 718132. The devices are used for radiological guidance and visualization during diagnostic, interventional and…
Philips North America Llc · A wireless foot switch pedal may get stuck in the active position when the user releases the pedal, resulting in the emission of unintended radiation.
- Zenition 70. The device is to be used in health care facilities both inside and outside the operating room, sterile as well as non-sterile…
Philips Medical Systems Nederland B.V. · Philips has become aware of the potential for unintended radiation exposure with Zenition 70 systems with Vascular Extension option and a Wireless Foot Switch.
- Merit Medical, REF: R2007, EsophyX Z+, (1) Fastener Delivery Device, SterileEO, RxOnly
Merit Medical Systems, Inc. · Update to IFU to provide additional information related to risk with device over-rotation and multiple deployment of fasteners.
- Merit Medical , REF: R2275, EsophyX Z+ with SerosaFuse Implantable Fasteners, (1) Fastener Delivery Device, (2) 7.5mm Cartridges, STERILEEO…
Merit Medical Systems, Inc. · Update to IFU to provide additional information related to risk with device over-rotation and multiple deployment of fasteners.
- Amplatzer TorqVue LP Delivery System (TVLP), Model nos. 9-TVLP4F90/060 and 9-TVLP4F90/080
Abbott · Device may have a small breach in the proximal end of the shaft under the strain relief of the delivery system. Breach is not visibly detectable and may lead t…
- Amplatzer TorqVue LP Catheter (TVLPC), Model no. 9-TVLPC4F90/080
Abbott · Device may have a small breach in the proximal end of the shaft under the strain relief of the delivery system. Breach is not visibly detectable and may lead t…
- Zimmer Biomet Ceramic Head, 22.2 mm Diameter, 12/14 Taper, +0 Neck, Model Number 802602202; Prosthesis, Hip, Semi-Constrained, Metal/Cerami…
Zimmer, Inc. · The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm Diameter Ceramic Femoral Heads with cobalt-chrome…
- Zimmer Biomet Ceramic Head, 22.2 mm Diameter, 12/14 Taper, +3 Neck, Model Number 802602203; Prosthesis, Hip, Semi-Constrained, Metal/Cerami…
Zimmer, Inc. · The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm Diameter Ceramic Femoral Heads with cobalt-chrome…
- Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, -3 Neck, Model Number 802802201; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Pol…
Zimmer, Inc. · The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm Diameter Ceramic Femoral Heads with cobalt-chrome…
- Zimmer Biomet Ceramic Head, 22.2 mm Diameter, Type 1, +0 Neck, Model Number 802802202; Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Pol…
Zimmer, Inc. · The associated product labeling does not adequately provide compatibility information for use of the 22.2 mm Diameter Ceramic Femoral Heads with cobalt-chrome…
Device clearances and approvals
FDA date:FDA decided 6 510(k)s and 5 PMA decisions on Mon, Apr 14.
- Any-Com Flow
Mediclus Co., Ltd. · Dental
- STERRAD® 100NX Sterilizer with ALLClear Technology (10104)
Advanced Sterilization Products, Inc. · General Hospital
- AVAVA Skin Treatment System
AVAVA, Inc. · General, Plastic Surgery
- Merge Universal Viewer (MUV)
Merge Healthcare Incorporated · Radiology
- Elfor-L
Elfi-Tech , Ltd. · Cardiovascular
Label updates
FDA date:90 drug labels took effect on Mon, Apr 14; 7 of the 25 read for this issue are for products in MedGrid's categories. Below: those, and labels carrying a boxed warning.
- Baby Mantra Diaper Cream
ZINC OXIDE 10% · Renu Laboratories, LLC · TOPICAL
- REPAIRWEAR UPLIFTING FIRMING BROAD SPECTRUM SPF 15 DRY
OCTINOXATE, OCTISALATE, AND TITANIUM DIOXIDE · CLINIQUE LABORATORIES LLC · TOPICAL
- Tadalafil
TADALAFIL · Aphena Pharma Solutions - Tennessee, LLC · ORAL
- Bumetanide
BUMETANIDE · Camber Pharmaceuticals, Inc. · INTRAMUSCULAR, INTRAVENOUS
- Ramipril
RAMIPRIL · A-S Medication Solutions · ORAL
- Diazepam
DIAZEPAM · Advanced Rx of Tennessee, LLC · ORAL
How the FDA daily is written
Every issue is written from FDA's public data (openFDA) and nothing else: the counts, names, firms and reasons are FDA's own. openFDA posts each kind of record on its own delay, so each section covers one FDA date and says which. Shortages cover yesterday; approvals, drug and device recalls, and food and supplement recalls cover a week ago; device clearances and label changes cover two weeks ago. Every FDA date appears in exactly one issue. Complete response letters appear the day after FDA publishes a batch.
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