Listed below are the drug, biologics and medical device recalls that may impact your ASC. Although ASCA makes every attempt to ensure this information is as complete and current as possible, ASCA cannot guarantee this as an exhaustive list of every recall that may impact your business. For the most up-to-date information on drug, biologics and medical device recalls, please visit the FDA web site.
Recall of System 83 Plus Automated Endoscope Reprocessors by Custom Ultrasonics for Reprocessing Duodenoscopes
August 18, 2016
The FDA is notifying health care facilities of Custom Ultrasonics' May 6, 2016 urgent medical device recall and advising users to stop using its System 83 Plus AERs for reprocessing of duodenoscopes. Based on the Agency’s February 2016 Safety Communication, at this time, facilities should have transitioned to alternative methods of reprocessing of duodenoscopes. In addition, FDA is revising its February 2016 Safety Communication to communicate that Custom Ultrasonics’ System 83 Plus AERs remain in service for the reprocessing endoscopes other than duodenoscopes.
Recall of Sterile Drug Products from Medaus Pharmacy
April 4, 2016
The U.S. Food and Drug Administration (FDA) is alerting health care professionals and patients not to use unexpired drug products that are intended to be sterile that were produced by Medaus Pharmacy in Birmingham, Alabama, due to lack of sterility assurance. Medaus’ products were distributed nationwide and internationally.
Recall of Compounded Products by Reliable Drug Pharmacy
March 28, 2016
Reliable Drug Pharmacy is recalling all unexpired lots of compounded products due to concern of lack of quality assurance and potential mislabeling. All unexpired lots are subject to the recall. All recalled products were distributed to patients and veterinarians within California. A few products were shipped to Hawaii, New Mexico, and Michigan. The recall was issued after a series of onsite inspections by the FDA.
Recall of Human and Animal Sterile Drug Products from I.V. Specialty
March 9, 2016
The U.S. Food and Drug Administration (FDA) is alerting health care professionals and patients not to use drug products intended to be sterile that are produced and distributed by I.V. Specialty Ltd., Austin, Texas, due to lack of sterility assurance. On March 7, 2016, FDA recommended that I.V. Specialty cease sterile production until appropriate corrective actions are implemented, and recall all non-expired drug products intended to be sterile. The company has neither ceased sterile production nor initiated a recall. Therefore, FDA is alerting health care professionals and patients to dispose of and not use drug products intended to be sterile that were produced and distributed by I.V. Specialty.
Recall of Sterile Products from Abbott's Compounding Pharmacy
January 16, 2016
Abbott's Compounding Pharmacy is voluntarily recalling all unexpired lots of sterile compounded products due to concerns of lack of sterility assurance. All unexpired lots are subject to the recall. These include injectable medications, sterile solutions, eye drops, and eye ointments.
All recalled products were distributed to patients, physician offices and clinics, and veterinarians within California.
All recalled products have a label that includes the Abbott's Compounding Pharmacy name and expiration date. If unsure, Customers can call the pharmacy to determine the expiration date. This recall impacts all sterile products distributed between 01/01/2015 and 01/14/2016.
New Reprocessing Instructions Validated for Olympus Duodenoscope Model TJF-Q180V
January 15, 2016
The FDA cleared the TJF-Q180V duodenoscope 510(k) with design modifications to the elevator channel sealing mechanism to create a tighter seal and reduce the potential for leakage of patient fluids and tissue into the closed elevator channel.
FUJIFILM Medical Systems, U.S.A., Inc. Validates Revised Reprocessing Instructions for Model ED-530XT Duodenoscopes
December 23, 2015
Fuji issued revised, validated manual reprocessing instructions for the ED-530XT duodenoscope to replace those provided in the original device labeling. The FDA reviewed the revised reprocessing instructions and the validation data and determined they meet the Agency’s expectations. We recommend that facilities using Fuji’s ED-530XT duodenoscope train staff on the new instructions and implement them as soon as possible.
Perseus A500 Anesthesia Workstation by Draeger: Class I Recall - Faulty Power Switch May Cause Device to Stop Working
December 23, 2015
Draeger is recalling the Perseus A500 anesthesia workstation because a faulty power switch may fail, causing the workstation to alarm and shut down unexpectedly. If this occurs, ventilation may fail and the patient may not receive either anesthesia or enough oxygen. This could cause patients to suffer serious adverse health consequences, including injury or death. The recall includes all Draeger Perseus A500 anesthesia workstations manufactured from June 1, 2013 to September 30, 2015 with distribution dates of February 1, 2015 to September 30, 2015. See the FDA Recall Notice for a link to a list of affected serial numbers.
The company has received one report of this issue occurring, with no injuries and no deaths.
Endoscope Washer/Disinfectors by Custom Ultrasonics: Safety Communication - FDA Recommends Health Care Facilities Transition to Alternate Reprocessing Methods
November 13, 2015
In accordance with a Consent Decree entered in January 2007 with Custom Ultrasonics, the FDA ordered Custom Ultrasonics to recall all of its Automated Endoscope Reprocessors (AERs) from health care facilities due to the firm’s continued violations of the Federal Food, Drug, and Cosmetic Act (FD&C Act), applicable regulations, and the Consent Decree. FDA is recommending that health care facilities currently using Custom Ultrasonics AERs transition away from their use to alternative methods to reprocess flexible endoscopes as soon as possible.
Downing Labs, LLC Sterile Compounded Products: Recall - Lack of Sterility Assurance
October 21, 2015
Downing Labs, LLC is voluntarily recalling all lots of sterile products compounded and packaged by Downing Labs and that remain within expiry due to concerns over sterility assurance. The products were distributed nationwide and in the UK to patients and providers between April 20, 2015 and September 15, 2015. If there is a contamination in products intended to be sterile, patients are at risk of serious infections which may be life threatening.
Acetaminophen Tablets by Medline Industries: Recall - Mislabeling with Incorrect Strength
October 9, 2015
On October 9, 2015, Medline Industries, Inc. announced that it will initiate a voluntary nationwide recall of lot # 45810 of Acetaminophen tablets, 500mg, uncoated compressed tablets to the consumer level. The Acetaminophen 500mg, Tab 100/BT (OTC20101) has been found to be mislabeled displaying “Acetaminophen 325mg” (OTC10101) instead of “Acetaminophen 500mg”. The Acetaminophen tablets, 500mg is incorrectly labeled as 325 mg tablets. This error is not easily identifiable by the user or prescriber. If the product is taken at the maximum labeled dose, every four hours, five doses a day, or with other medications containing acetaminophen, it may lead to liver toxicity or liver failure. See the firm Press Release for further details.
Sterile Compounded Products by US Compounding, Inc: Recall - Lack of Sterility Assurance
Hospira Recalls One Lot of Preservative-Free Bupivacaine HCl Injection
April 27, 2014
September 24, 2015
US Compounding, Inc. is voluntarily recalling all lots of sterile products aseptically compounded and packaged by USC and that remain within expiry due to FDA concern over a lack of sterility assurance. The sterile products were distributed nationwide to patients, providers, hospitals, or clinics between March 14, 2015 and September 9, 2015. If the sterility of a compounded preparation intended to be sterile is compromised, patients may be at risk.
Hospira issued a voluntary recall of one lot of Preservative-Free Bupivacaine HCl Injection, USP, 0.5% (5 mg/mL), 30 mL Single-dose due to one confirmed customer complaint of iron oxide particulate in glass vials.
Select Lots of Baxter IV Solutions Recalled
April 10, 2015
Baxter International Inc. is voluntarily recalling select lots of intravenous (IV) solutions to the hospital/user level due to the potential presence of particulate matter.
Products Recalled from Prescription Center Pharmacy in Fayetteville, NC
April 3, 2015
FDA is joining the North Carolina Board of Pharmacy to urge health care professionals and patients not to use products made and distributed by the Prescription Center pharmacy, located at 915 Hay St., Fayetteville, North Carolina.
Hospira Issues a Voluntary Nationwide Recall of One Lot of Lactated Ringer's Irrigation Due to Mold Contamination
March 12, 2015
Anyone with an existing inventory of the recalled lot should stop use and distribution, and quarantine the product immediately. Customers should notify all users in their facility.
Hospira Announces Recall of 0.9 Percent Sodium Chloride Injection
March 6, 2015
Hospira announced a voluntary nationwide recall of one lot of 0.9% Sodium Chloride Injection, USP, 250 mL VisIV flex container to the user level due to one confirmed customer report of particulate in a single unit.
FDA Issues Endoscope Warning Following Superbug Outbreak
February 20, 2015
The FDA wants to raise awareness among health care professionals that the complex design of duodenoscopes may impede effective reprocessing.
Hospira Recalls Ketorolac Tromethamine Injection
February 11, 2015
Hospira announced a voluntary recall of ketorolac tromethamine injection, USP in the United States and Singapore due to potential particulate. The presence of particulate has been confirmed through a customer report of visible, floating particulate identified in glass fliptop vials.
Hospira Recalls 0.9 Percent Sodium Chloride Injection
January 27, 2015
Hospira, Inc. announced a voluntary nationwide recall of one lot of 0.9% Sodium Chloride Injection, USP, 250 mL (NDC 0409-7983-02, Lot 44-002-JT, Expiry 1AUG2016) to the user level due to one confirmed customer report of particulate in a single unit.
FDA Warns Health Care Professionals Not to Inject Patients with Wallcur IV Solutions
January 5, 2015
The FDA is alerting health care professionals not to use Wallcur, LLC, simulated intravenous (IV) products in human or animal patients. There have been reports of serious adverse events associated with the use of certain of these products – i.e., Practi IV Solution Bags.
Baxter Recalls 0.9 Percent Sodium Chloride Injection USP
December 16, 2014
axter International Inc. initiated a recall in the United States of two lots of 0.9% Sodium Chloride Injection USP in 100 mL MINI-BAG PLUS Container to the hospital/user level.
Hospira Recalls One Lot of 1% Lidocaine HCI for Injection
October 20, 2014
Hospira announced it will initiate a voluntary recall of one lot of 1% Lidocaine HCI for Injection, USP, 10 mg per mL, 30 mL Single-dose, Preservative-Free to the user level due to a confirmed customer report of particulate in a single unit.
LifeCare Flexible Intravenous Solutions by Hospira, Inc. Recalled
October 15, 2014
Hospira, Inc. announced the voluntary recall of certain lots of several products in its LifeCare line of flexible intravenous solutions due to the potential for leakage.
Recall of Sterile Products from Oregon Compounding Centers, Inc.
October 10, 2014
Oregon Compounding Centers, Inc. (also called Creative Compounds) is voluntarily recalling certain unexpired human and veterinary sterile products to the consumer level due to lack of sterility assurance.