Magnesium Sulfate 1 GM in NS 50 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
CMC Enterprise Pharmacy
💊 Drugs Class I - Dangerous
Lack of sterility assurance.
All Recalls
95,050 total recalls in our database
💊 Drugs Class I - Dangerous
Failed impurities/degradation specification: Out of Specification result for total impurity at 4.0% (Limit: NMT 3.0%) at 12 months stability testing.
Vancomycin 1750 mg in 0.9% Sodium Chloride 500 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
CMC Enterprise Pharmacy
💊 Drugs Class I - Dangerous
Lack of sterility assurance.
Vancomycin 1000 mg in NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
CMC Enterprise Pharmacy
💊 Drugs Class I - Dangerous
Lack of sterility assurance.
Phenylephrine 20 mg NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
CMC Enterprise Pharmacy
💊 Drugs Class I - Dangerous
Lack of sterility assurance.
CeFAZolin 1 GM a) in NS 100 mL bag; b) 100 mg/mL (10 mL) syringe, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
CMC Enterprise Pharmacy
💊 Drugs Class I - Dangerous
Lack of sterility assurance.
Diltiazem 250 mg in NS 250 mL bag, Made by: Enterprise Pharmacy, 4400 Golf Acres Drive, Bldg. J Suite E, Charlotte, NC, 28208.
CMC Enterprise Pharmacy
💊 Drugs Class I - Dangerous
Lack of sterility assurance.
🏥 Medical Devices Class I - Dangerous
When the user performs the re-assignment of a parent / companion pair, the parent volume is transferred to the new patient but the companion volume will remain in the original patient s exam.
🏥 Medical Devices Class I - Dangerous
Small black plastic particle was observed in the left ventricle during implant procedure.
Difficulty with atrioseptostomy catheter balloon deflation after deployment, and reports of balloon fragmentation or detachment.
Sterilization method used was not consistent with the labeling and the approved sterilization method
🏥 Medical Devices Class I - Dangerous
One of the software algorithms used to detect sample dispense errors was inadvertently disabled. Because of this, sample dispense errors may lead to incorrect results being reported without an error code to alert the user.
🏥 Medical Devices Class I - Dangerous
Advisory issued not to disable or bypass the AMP function. Disabling or bypassing the AMP function for reasons of comfort is not advisable may lead to patient or user injury due to collision with LINAC equipment disabling the Auto Field Sequence (AFS) Automatic Motion Protection (AMP) function implemented at the control of the Digital Linear Accelerator.
🏥 Medical Devices Class I - Dangerous
Sterilization method used was not consistent with the labeling and the approved sterilization method
Difficulty with atrioseptostomy catheter balloon deflation after deployment, and reports of balloon fragmentation or detachment.
cone-beam CT system
KaVo Dental Technologies
🏥 Medical Devices Class I - Dangerous
ORTHOPANTOMOGRAPH OP 3D device has a defect in the device firmware versions 2.1.0 and 2.1.1
🏥 Medical Devices Class I - Dangerous
The device is recalled due to donor ineligibility of released human tissue. The firm received information that the tissue donor's blood culture tested positive for Enterobacter cloacae.
🏥 Medical Devices Class I - Dangerous
Devices may generate excessive heat during use.
🏥 Medical Devices Class I - Dangerous
There is an error in the chromomap included in the labeling for the product.
Sterilization method used was not consistent with the labeling and the approved sterilization method