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Medical Device Recalls | FDA
- https://www.fda.gov/medical-devices/medical-device-safety/medical-device-recalls
- If you wish to find information on a recall, or a correction or removal action that has not yet been classified, you can search the Medical Device Recalls Database. Please note that the FDA...
Covidien, LLC (Medtronic) Recalls Palindrome and …
- https://www.fda.gov/medical-devices/medical-device-recalls/covidien-llc-medtronic-recalls-palindrome-and-mahurkar-hemodialysis-catheters-due-catheter-hub
2022 Medical Device Recalls | FDA
- https://www.fda.gov/medical-devices/medical-device-recalls/2022-medical-device-recalls
- Subscribe to Medical Device Safety and Recalls Sign up to receive email updates on medical device recalls, safety communications, and other safety information. Enter your …
Smiths Medical Issues Urgent Medical Device Correction …
- https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/smiths-medical-issues-urgent-medical-device-correction-letter-notifying-customers-potential-issues
- Company Announcement MINNEAPOLIS, Dec. 12, 2022 /PRNewswire/ -- Smiths Medical issued an Urgent Medical Device Correction Letter to notify affected customers of two …
URGENT DEVICE RECALL - Food and Drug …
- https://www.fda.gov/media/84668/download
- For radiation-emitting electronic products, a recall action is governed by 21 CFR 1004 – Repurchase, Repairs, or Replacement of Electronic Products – under which …
Medical Device Recall Information - Philips …
- https://www.usa.philips.com/healthcare/e/sleep/communications/src-update
- The following products listed are affected by the recall notification / field safety notice: CPAP and BiLevel PAP Devices All Affected Devices Manufactured Before …
Customer Recall Notifications - Food and Drug …
- https://www.fda.gov/media/82609/download
- RecallN otification Greeting& Purpose RecommendedforClassIandIIrecalls.“Urgent” shouldbenotedonboththeletterandenvelopeasper 21CFR7.49(4)(b). 2 Forradiation …
URGENT: MEDICAL DEVICE RECALL - icumed.com
- https://www.icumed.com/media/15525/ma2207-01_customer-letter.pdf
- Urgent: Medical Device Recall Frequently Asked Questions ICU Medical is issuing a medical device recall letter informing affected customers of a potential defect …
Medical Device Recall Communication - FDAnews
- https://www.fdanews.com/ext/resources/files/Conference2/MDQC15Presentations/Brown-Recalls-Communicating-With-FDA.pdf
- (c)Contents. (1) A recall communication shouldbe written in accordance with the followingguidelines: (i) Be brief and to the point; (ii) Identify clearly the product, size, …
Sample Recall Letters - Prime Clinical
- http://www.primeclinical.com/docs/Intellect/Sample_Recall_Letters.htm
- SAMPLE RECALL LETTERS. Following are samples of all pre-loaded recall letters available in Intellect. Scroll through the samples, OR click on a link in the alphabetized list …
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