สรุปข่าวความปลอดภัยของผลิตภัณฑ์สุขภาพ ประจำเดือน ธันวาคม 2563 รวม 25 เรื่อง โดยแบ่งเป็นข่าวเกี่ยวกับผลิตภัณฑ์ยา 12 เรื่อง เครื่องมือแพทย์ 12 เรื่อง และอาหาร 1 เรื่อง ดังนี้
1. Hong Thai Foods Corp Issues Allergy Alert on Undeclared Milk Allergens in Golden Boy Custard Muffin Original
2. WishGarden Herbs Issues Voluntary National Recall of 46 Units of Happy Ducts Compress Due to Bacterial Contamination
3. Baxter Healthcare Recalls Baxter SIGMA Spectrum Infusion Pumps with Master Drug Library (Versions 6 and 8) and Spectrum IQ Infusion Systems with Dose IQ Safety Software Due to Unplanned Shutdown Issues
4. Revision of Precautions (No.318)
5. MPM Medical LLC Issues Voluntary Nationwide Recall of Regenecare HA Hydrogel Due to Burkholderia cepecia Contamination
6. WishGarden Herbs Issues Voluntary Nationwide Recall of Cord Care and Goldenseal Powder Due to Bacterial Contamination
7. Field Safety Notice – Urgent Medical Device Recall AXIOS Stent and Electrocautery – Enhanced Delivery System, and Hot AXIOS Stent and Electrocautery – Enhanced Delivery System
8. Revision of Precautions
9. Antidepressant utilisation and risk of suicide in young people
10. Risk of drug-induced liver injury associated with the use of pirfenidone
11. Advisory on restriction on the use of montelukast and neuropsychiatric effects
12. Class I Hazard Alert – EMBLEM S-ICD Subcutaneous Electrode (Model 3501)
13. Safety advisory – Use of face masks during MRI examinations
14. Class 2 Medicines Recall: Merck Sharp & Dohme Limited, Zerbaxa 1g/0.5g Powder for Concentrate for Solution for Infusion, EL (20)A/60
15. Class I Product Defect Correction – Rotor Bearing Screws for Nuclear Medicine Systems
16. Urgent Recall Notice – CIRRUS2 NEBULISER, ADULT, INTERSURGICAL ECOLITE MASK KIT WITH TUBE, 2.1M
17. URGENT: MEDICAL DEVICE VOLUNTARY RECALL – AXS Universal Aspiration Tubing
18. Urgent Field Safety Notice – Antibiotic Impregnated (ARES?) Catheters
19. Urgent Field Safety Notice – Delta? Neonatal Valves
20. Tenofovir Disoproxil Emtricitabine Mylan 300/200 Recall – potential for split tablets to lead to ineffective dose
21. Zostavax vaccine Safety advisory – risk of infection with the vaccine virus
22. Cook Medical Recalls Flexor Check-Flo Introducers and Flexor Tuohy-Borst Side-Arm Introducers Due to Separation in Device
23. Class I Recall – Quadrox-I Pediatric Oxygenator HMO 31000 with Pediatric Venous Hardshell Cardiotomy Reservoir VHK 31000
24. RECALL – TLAB Transjugular Liver Biopsy System
25. REMOVAL – Multiple Sterile Zimmer Biomet Products
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