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[Recalled] Unity Total Knee System, Model Number 112.001.34. Primary and revision total knee arthroplasty — Potential for Unity CR Inserts Right size 6 from batch 529803 to be incorrectly… | FDA 2023-10-13

FDA recall notice for Unity Total Knee System, Model Number 112.001.34. Primary and revision total knee arthroplasty (Corin Ltd). Reason: Potential for Uni

[Recalled] Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020 when using Tempus LS-Manual User/Operator Manual — Simultaneous ECG measurements with multiple devices, including a manual defibri… | FDA 2024-05-09

FDA recall notice for Philips Tempus LS-Manual Defibrillator, Part Number: 00-3020 when using Tempus LS-Manual User/Operator Manual (Remote Diagnostic Technolog

[Recalled] HeartSine samaritan PAD (Public Access Defibrillator), Type: SAM 350P, SAM 360P, SAM 450P — Automated external defibrillators have a manufacturing issue that could prevent… | FDA 2024-04-08

FDA recall notice for HeartSine samaritan PAD (Public Access Defibrillator), Type: SAM 350P, SAM 360P, SAM 450P (HeartSine Technologies Ltd). Reason: Automated

[Recalled] RENASYS EDGE The RENASYS¿ EDGE pump is indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound healing via removal of fluids, including irrigation fluids and body fluids, wound exudate and

FDA recall notice for RENASYS EDGE The RENASYS¿ EDGE pump is indicated for patients who would benefit from a suction pump (NPWT), as it may promote wound hea

[Recalled] McKesson Calcium Alginate Dressing MFR# 3562 Wound dressing indicated for moderate to heavily exuding chronic and acute wounds, and to control minor bleeding in superficial wounds. — Due to defects on primary packaging pouch t

FDA recall notice for McKesson Calcium Alginate Dressing MFR# 3562 Wound dressing indicated for moderate to heavily exuding chronic and acute wounds, and to

[Recalled] Hollister CalciCare Calcium Alginate Dressing REF 529937R calcium alginate dressings are indicated for moderate to heavily exuding chronic and acute wounds such as: ¿ pressure ulcers ¿ leg ulcers ¿ cavity wounds ¿ lacerati

FDA recall notice for Hollister CalciCare Calcium Alginate Dressing REF 529937R calcium alginate dressings are indicated for moderate to heavily exuding chro

[Recalled] MEDLINE MAXORB EXTRA ALGINATE WOUND DRESSING 4X4 SQUARE REF MSC7044EP MEDLINE MOXORB EXTRA ALBINATE WOUND DRESSING 4X8 RECTANLE REF MSC7048EP Wound dressing indicated for moderate to heavily exuding chronic and acute wounds,

FDA recall notice for MEDLINE MAXORB EXTRA ALGINATE WOUND DRESSING 4X4 SQUARE REF MSC7044EP MEDLINE MOXORB EXTRA ALBINATE WOUND DRESSING 4X8 RECTANLE REF MSC70

[Recalled] Lev5, REF CT1587B, 50 Susceptibility discs Levofloxacin 5 ug, IVD, CE 2797 — Mislabeling | FDA 2024-12-23

FDA recall notice for Lev5, REF CT1587B, 50 Susceptibility discs Levofloxacin 5 ug, IVD, CE 2797 (Oxoid Limited). Reason: Mislabeling. Issued 2024-12-23.

[Recalled] Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catalog Number: LP3403 — Lipoprotein (a) on Roche Cobas c501 with nmol/l claims does not have a 510(k) o… | FDA 20

FDA recall notice for Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catalog Number: LP3403

[Recalled] Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catalog Number: LP2757 — Lipoprotein (a) on Roche Cobas c501 with nmol/l claims does not have a 510(k) o… | FDA 202

FDA recall notice for Randox Lipoprotein (a) - In vitro diagnostic (IVD) use as Randox Lipoprotein (a) assay on automated analysers. Catalog Number: LP2757 (

[Recalled] Eclipse Mini REF 98900 The Eclipse MINI Model 98900 is a portable non-invasive continuous ambulatory ECG patch recorder intended to record the patient s electrocardiogram. — Due to a manufacturing error the incorrect device se

FDA recall notice for Eclipse Mini REF 98900 The Eclipse MINI Model 98900 is a portable non-invasive continuous ambulatory ECG patch recorder intended to rec

[Recalled] Eclipse PRO REF 98700 The Spacelabs model 98700 is a portable non-invasive Holter recorder intended to record the patient s ambulatory electrocardiogram. — Due to a manufacturing error the incorrect device serial number was po

FDA recall notice for Eclipse PRO REF 98700 The Spacelabs model 98700 is a portable non-invasive Holter recorder intended to record the patient s ambulatory

[Recalled] Philips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R, 00-1004, 00-1007 — Patient Monitor software update to address issues:1)May freeze at startup with… | FDA 2025-04-15

FDA recall notice for Philips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R, 00-1004, 00-1007 (Remote Diagnostic Technologies Ltd

[Recalled] Brand Name: Quantum Informatics - VIPER Product Name: Monitor, Physiological, Patient (Without Arrhythmia Detection or Alarms) Product Description: VIPER is a software-only device (SaMD) that is intended to provide near real-ti

FDA recall notice for Brand Name: Quantum Informatics - VIPER Product Name: Monitor, Physiological, Patient (Without Arrhythmia Detection or Alarms) Product D

[Recalled] Initiation 3 Month Heavy Flow Bundle; Model Number: FG-BNDL-PC-MM-IBHF; — Product lacks 510(k) clearance | FDA 2025-02-17

FDA recall notice for Initiation 3 Month Heavy Flow Bundle; Model Number: FG-BNDL-PC-MM-IBHF; (DAYE (ANNE'S DAY LTD)). Reason: Product lacks 510(k) clearance.

[Recalled] Refill 36 Coated Super Tampons; Model Number: FG-TMP-MM-REF00360000; — Product lacks 510(k) clearance | FDA 2025-02-17

FDA recall notice for Refill 36 Coated Super Tampons; Model Number: FG-TMP-MM-REF00360000; (DAYE (ANNE'S DAY LTD)). Reason: Product lacks 510(k) clearance. Iss

[Recalled] Refill 3 Month Heavy Flow Bundle; Model Number: FG-BNDL-PC-MM-REFHF; — Product lacks 510(k) clearance | FDA 2025-02-17

FDA recall notice for Refill 3 Month Heavy Flow Bundle; Model Number: FG-BNDL-PC-MM-REFHF; (DAYE (ANNE'S DAY LTD)). Reason: Product lacks 510(k) clearance. Iss

[Recalled] Refill 18 Coated Super and 18 Nude Super Tampons; Model Number: FG-TMP-MM-REF00180018; — Product lacks 510(k) clearance | FDA 2025-02-17

FDA recall notice for Refill 18 Coated Super and 18 Nude Super Tampons; Model Number: FG-TMP-MM-REF00180018; (DAYE (ANNE'S DAY LTD)). Reason: Product lacks 510

[Recalled] Heavy Flow Bundle; Model Number: FG-BNDL-PC-REFHF; — Product lacks 510(k) clearance | FDA 2025-02-17

FDA recall notice for Heavy Flow Bundle; Model Number: FG-BNDL-PC-REFHF; (DAYE (ANNE'S DAY LTD)). Reason: Product lacks 510(k) clearance. Issued 2025-02-17.

[Recalled] Initiation 3 Month Regular Flow Bundle; Model Number: FG-BNDL-PC-MM-IBRF; — Product lacks 510(k) clearance | FDA 2025-02-17

FDA recall notice for Initiation 3 Month Regular Flow Bundle; Model Number: FG-BNDL-PC-MM-IBRF; (DAYE (ANNE'S DAY LTD)). Reason: Product lacks 510(k) clearance