Reason: Potential for compromised integrity of the sterile packaging.
Distributed: US Nationwide distribution in the states of AL, AZ, CA, CT, DE, FL, GA, ID, IL, MD, MI, MN, MO, MS, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI.Reason: Potential for compromised integrity of the sterile packaging.
Distributed: US Nationwide distribution in the states of AL, AZ, CA, CT, DE, FL, GA, ID, IL, MD, MI, MN, MO, MS, NE, NJ, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI.Reason: The fastening post hardware could loosen allowing the fastening post to detach from the cot
Distributed: US Nationwide distribution in the states of AL, AR, AZ, CA, CO, FL, IS, IL, KY, LA, MN, MO, NC, ND, NE, NM, NY, OH, OK, PA, TN, TX, UT, VA, WI, WV.Reason: The failure occurs if a user on the Omnipod 5 iOS application selects and holds down on a manual entry field, to magnify the visual field using the magnifying feature of the iPhone, while simultaneously selecting a single number on the keyboard. This causes the single digit number to duplicate. This could result in errors in manual entry of digits - examples: bolus entry, I:C ratio, bolus calculator, prior to starting the bolus insulin delivery. Therefore, this may result in over delivery of insulin which may cause hypoglycemia.
Distributed: US Nationwide distribution.Reason: Carotid stent and post-dilation balloon system with integrated embolic protection system has an integrated filter that may not open or may not fully open during sheath retraction and operation of the filter knob. The stent is used with a primary distal embolic protection device.
Distributed: US Nationwide distribution in the states of FL, CO, CA, IL, NC, KY, TX, PA, DE, NJ, IN, NY, OH, LA, OK, SC, CT, WI, MA, KS, UT, MD, AL.Reason: Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
Distributed: WorldwideReason: Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
Distributed: WorldwideReason: Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
Distributed: WorldwideReason: Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
Distributed: WorldwideReason: Abbott has become aware of a limited number of tip detachment events during catheter removal from the packaging.
Distributed: Worldwide