FDA Recalls and Updates
One lot of Sodium Chloride Injection, 0.9 percent, 1000 mL, Flexible Container:
Recall for Brass Particulates (4/1/13)
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm346011.htm?source=govdelivery
Med Prep Consulting Inc. announced a voluntary nationwide recall of all lots of
their compounded products today (3/19/13).
http://www.medprepusa.com/20130318-medprep-consulting-inc-announces-voluntary-nationwide-recall-of-all-lots-of-all-compounded-products-due-to-potential-mold-contamination
Recall Of Medprep Consulting Magnesium Sulfate 2gm In Dextrose 5 percent In
Water, 50ml For Injection Due To Mold Contamination
(3/16/13)
http://www.fda.gov/Safety/Recalls/ucm344189.htm?source=govdelivery
FDA Alert: Azithromycin (Zithromax or Zmax) (3/12/13)
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm343350.htm
Lactated Ringers and 5 Percent Dextrose Injection, USP, 1000ML, Flexible
Containers: Recall (1/28/13)
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm337089.htm?source=govdelivery
Moog Medical Device Group Announces Completion of Curlin Pump Recall (8/29/12)
Baxa Corporation Abacus Total Parenteral Nutrition (TPN)
Calculation Software (5/25/12)
http://www.fda.gov/MedicalDevices/Safety/RecallsCorrectionsRemovals/ListofRecalls/ucm305744.htm
Moog Medical Devices Group Announces Voluntary Recall Of
Select Curlin Administration Sets Due To Possible Health Risk
(5/22/12)
http://www.fda.gov/Safety/Recalls/ucm305208.htm?source=govdelivery
Recall of Several American Regent Injectable Products:
Visible Particulates in Products (4/4/12)
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm242365.htm?source=govdelivery
Diflucan (fluconazole): Drug Safety Communication –
Long-term, High-dose Use During Pregnancy May Be Associated With
Birth Defects (8/3/11)
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm266468.htm
FDA Warns Not to Feed SimplyThick to Premature Infants
(5/20/11)
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm256250.htm
Non-Sterile Boston Scientific Devices Stolen: Endoscopy and
Urology/Women's Health Devices--Risk of Infection (5/4/11)
http://www.fda.gov/ICECI/CriminalInvestigations/ucm253675.htm
Moog Recalls Curlin Ambulatory Infusion Pump Models 6000 CMS,
6000 CMS IOD, PainSmart, and PainSmart IOD (4/11/11)
http://www.fda.gov/Safety/Recalls/ucm250733.htm
Lansoprazole Delayed-Release Orally Disintegrating Tablets by
Teva Pharmaceuticals: Letter to Healthcare Professionals - Clogged, Blocked Oral
Syringes and Feeding Tubes (4/5/2011)
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm251575.htm
H & P Industries Povidine Iodine Prep Pads: Recall -
Potential Microbial Contamination (3/18/11)
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm247743.htm
American Regent Initiates
Voluntary Nationwide Recall of Bacteriostatic Sodium Chloride Injection, USP,
0.9% 30 mL Multiple Dose Vials (3/17/11)
American Regent Initiates Voluntary Nationwide Recall of Bacteriostatic Sodium
Chloride Injection, USP, 0.9% 30 mL Multiple Dose Vials
Cook Inc., Single, Double, Triple and Five-Lumen Central
Venous Catheter Trays AND Single and Double Lumen PICC Peripheral Inserted
Central Venous Catheter Trays: Class I Recall - Leaks in Plunger Luer Detected
(3/3/11)
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm245634.htm
B. Braun Outlook 400ES Safety Infusion System, Model Number 621-400ES: Class I
Recall - Hardware May Become Unresponsive (2/1/11)
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm241637.htm
Triad Alcohol Prep Pads, Alcohol Swabs, and Alcohol Swabsticks: Recall Due to
Potential Microbial Contamination (1/6/11)
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm239319.htm
B. Braun addEASE Binary Connector: Class I Recall -Stopper Fragments May Enter
Bag (11/30/10)
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm235283.htm
WalkMed Infusion Issues Nationwide Recall of Triton Pole Mount Infusion Pumps
(11/24/10)
http://www.fda.gov/Safety/Recalls/ucm234902.htm
Propoxyphene: Withdrawal - Risk of Cardiac Toxicity (11/19/10)
Sigma Spectrum Infusion Pump Model 35700: Class 1 Recall: Risk of Over-Infusion (11/12/10)
Actavis Encourages Consumers to Return Fentanyl Transdermal System 25 mcg/h (11/4/10)
Actavis Inc. Issues a Voluntary Recall of 18 Lots of Fentanyl Transdermal System 25 (10/21/10)
CPSC and FDA Warn Against Using Infant Sleep Positioners (9/29/10)
Infant
Sleep Positioners Pose Suffocation Risk (9/29/10)
Abbott Voluntarily
Recalls Certain Similac® Brand Powder Infant Formulas That Did Not Meet Its
Quality Standards
FDA: Huber Needles (Two class I recalls)
Multi-Med, Inc., 22 Gauge x 1 inch Straight and Right Angle Huber Needles and
Navilyst Medical Inc., Vaxcel Implantable Vascular Access Systems Containing
Huber Needles (Two Class I Recalls) (8/26/10)
Inferior Vena Cava (IVC) Filters: Initial Communication: Risk of Adverse Events
with Long Term Use (8/9/10)
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm221707.htm
Baxter Colleague Infusion Pumps: FDA Ordering Recall (5/4/10)
FDA Launches Initiative to Reduce Infusion Pump Risks (4/23/10)
FDA Cites Makers of Tysabri (3/25/10)
FDA - Recalls of Q-Syte™ Luer Access Split Septum (3/17/10)
FDA Issues Huber Infusion Needle Recall
FDA Cites Sentinel EN Pump Maker