Date Issued: June 25, 2021 The U.S. Food and Drug Administration (FDA) is providing updated information about medical device adverse event reports and recommendations for health care providers on bronchoscopes. This is a supplement to the 2015 safety communication on reprocessed flexible bronchoscopes. Recommendations for Patients and Caregivers The recommendations have not changed from the…
Smiths Medical Recalls Jelco Hypodermic Needle-Pro Fixed Needle Insulin Syringes for Skewed Graduated Marks on Syringe Barrel That May Cause Insulin Overdose or Underdose
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Jelco Hypodermic Needle-Pro Fixed Needle Insulin Syringes Models and Lot Model Number Name Lot Number 4428-1 Jelco Hypodermic Needle-Pro Fixed Needle Insulin Syringe 28Gx1/2” 1CC 4046543, 4062235…
Avid Medical Recalls Medical Convenience Kits for Risk of Fungal Contamination
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Adult Chest Tube Tray Fistula On-Off Kit Fistula (On/Off All in One bag) Dialysis Access Part and Lot Numbers: See “Full List of Affected Devices” Distribution Dates:…
DeRoyal Industries Recalls Surgical Procedure Packs for Mislabeled Lidocaine
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product DeRoyal Pacemaker Tray Pgybk Lot Number 54239375, exp. 02/01/2022 DeRoyal Heart Cath Procedure Pack Lot Numbers: 54310362, exp. 01/01/2022; 54366825, exp. 01/01/2022 DeRoyal Angio Cath Removal Tray…
Prairie Wolf Spirits, Inc. Issues Voluntary Nationwide Recall of Prairie Wolf Distillery Hand Sanitizer Packed in 16.9 Oz. and 20 Oz Bottles Because They Resemble Drink Containers
Summary Company Announcement Date: June 21, 2021 FDA Publish Date: June 22, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Packaged in containers resembling water bottles Company Name: Prairie Wolf Spirits, Inc. Brand Name: Brand Name(s) Prairie Wolf Distillery Product Description: Product Description Hand sanitizer packaged in 16.9 fluid ounce and 20 fluid…
Sanit Technologies Adds Label Clarification to Existing Voluntary Hand Sanitizer Recall
Summary Company Announcement Date: June 19, 2021 FDA Publish Date: June 22, 2021 Product Type: Drugs Reason for Announcement: Recall Reason Description Microbial contamination Company Name: Sanit Technologies LLC d/b/a Durisan Brand Name: Brand Name(s) Product Description: Product Description Hand sanitizer and hand sanitizing wipes Company Announcement Sanit Technologies LLC d/b/a Durisan, is providing an…
Smiths Medical Issues Worldwide Notification Regarding the Recall of Jelco® Hypodermic Needle-Pro® Fixed Needle Insulin Syringe With Skewed Graduation Markings
Summary Company Announcement Date: June 16, 2021 FDA Publish Date: June 17, 2021 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Skewed odd number line graduation markings on syringe barrels. Company Name: Smiths Medical Brand Name: Brand Name(s) Product Description: Product Description Hypodermic Needle-Pro Fixed Needle Insulin Syringes Company Announcement Smiths Medical has…
Infusion Pump Repair Recalls Alaris Infusion Pump Module 8100 Bezel Due to Possible Cracked or Separated Bezel Repair Posts
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death. Recalled Product Alaris Infusion Pump Module Model 8100 Bezel, purchased and/or installed by Infusion Pump Repair Models: Alaris Model 8100 Product Number: TIPA-8100-4410 Lot Number: 20200608 Devices Recalled in…
Philips Issues a Recall Notification* to Mitigate Potential Health Risks Related to the Sound Abatement Foam Component in Certain Sleep and Respiratory Care Devices
Summary Company Announcement Date: June 14, 2021 FDA Publish Date: June 15, 2021 Product Type: Medical Devices Reason for Announcement: Recall Reason Description Potential health risks related to the polyester-based polyurethane (PE-PUR) sound abatement foam component in these devices Company Name: Philips Brand Name: Brand Name(s) Product Description: Product Description Philips Bi-Level Positive Airway Pressure…
Sodium Citrate Blood Specimen Collection Tube Conservation Strategies – Letter to Health Care and Laboratory Personnel
June 10, 2021 The U.S. Food and Drug Administration (FDA) is aware that the U.S. is experiencing significant interruptions in the supply of sodium citrate blood specimen collection (light blue top) tubes because of an increase in demand and recent vendor supply challenges. Recommendations The FDA recommends that health care providers, laboratory directors, phlebotomists, and…