Drug Recalls

Date:8/27/2021
Official Message No.:104523-8-27-2021-PHIN
Contact Info:
Attachments: No

Please review the following message from Alan Talarsky, Environmental Scientist 4, Public Health and Food Protection Program, NJDOH regarding the following Class 1 Recalls issued by the U.S. Food and Drug Administration: 1. On August 4, 2021, Cardinal Health (NYSE: CAH) initiated a nationwide recall of approximately 267 million MonojectTM Flush Prefilled Saline Syringes (0.9% Sodium Chloride). The products have been found to reintroduce air into the syringe after the air has been expelled. This could result in injection of air into blood vessels and create the potential for air embolism, which can cause serious adverse health outcomes or death. Customers who have affected product(s) should immediately review their inventory and quarantine and return all affected product. The recall applies to all lots of the products manufactured from July 2019 to June 2021 distributed between July 2019 and July 2021. The following SKUs have been recalled: Name of Product SKUs 12mL Syringe, 10 mL Saline Fill 8881570121 12mL Syringe, 3 mL Saline Fill 8881570123 12mL Syringe, 5 mL Saline Fill 8881570125 The Monoject™ 3mL syringe, 2.5mL Saline Fill is not affected by this recall. This item, SKU 8881570300, will be available for sale until inventory is depleted. MonojectTM Flush Prefilled Saline Syringes can be identified by the barrel of the syringe, the case and the box as shown in the pictures below: The company has received 37 reports of the plunger pulling back. No injuries have been reported to date.Cardinal Health voluntarily recalled MonojectTM Flush Prefilled Saline Syringes after learning that there is potential for the syringe’s plunger to draw back and reintroduce air back into the syringe. Cardinal Health has notified the U.S. Food and Drug Administration of this action. Cardinal Health notified its distributors and customers by overnight delivery of a notification packet on August 5, 2021 and is arranging for return of all recalled products. Cardinal Health distributes this product nationwide. Customers with questions may contact the market action team via telephone at 800-292- 9332 between the hours of 8 a.m. – 5 p.m. EST. Customers may also contact the team via email at GMB-FieldCorrectiveAction@cardinalhealth.com. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. • Complete and submit the report Online • Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178 Given the limited number of alternative prefilled saline syringe options, combined with ongoing supply, transportation and labor challenges, we anticipate that this recall may contribute to a market disruption of prefilled saline syringes. We are actively working to address the disruption and support customers’ needs with locating alternative supply and we suggest that clinicians work with their facility to determine alternative fill methods. For more information and the latest updates, please visit cardinalhealth.com/MonojectFlushPrefilledSalineSyringesIssueExternal Link Disclaimer. Contacts Media: Andrew Stern, andrew.stern@cardinalhealth.com and (614) 339-4678 ********************************************************************************* 2. Baxter International Inc. announced today it has issued an Urgent Medical Device Correction for all Spectrum IQ infusion pumps to reinforce important safety information when customers implement changes to their network configuration and server systems. Baxter previously communicated this information to customers via an Urgent Medical Device Correction notification on June 4, 2021 and a follow-up communication with updated informationExternal Link Disclaimer on August 2, 2021. Two Spectrum IQ infusion pump customers notified Baxter of system errors occurring in multiple pumps within their fleets following changes the customers implemented to the configuration of their network and server systems. Gateway Server System performance anomalies resulted in multiple pump connectivity errors, placing stress on the pump’s processor. When this occurs, pumps initiate a “watchdog” system error alarm to notify the user of the issue, causing the pump to enter a fail-safe mode which stops all pump processes, including delivery of fluid to the patient. For both customers, the watchdog system errors were resolved by restoring network and server system performance to expected levels. To date, there have been no reports of adverse events or patient injury associated with this issue. However, depending on several factors, such as the length of delay, medication being infused, the volume and rate of the infusion, patient status, and comorbidities, the patient may experience serious adverse health consequences or death. Baxter is developing a software upgrade for all Spectrum IQ infusion pumps that will assist how the pump responds to unstable network and server systems by reducing the stress on the pump’s memory and processing functions if this occurs. The updated software is currently expected to be available early in the fourth quarter of 2021, and Baxter will work with customers to schedule the software upgrades. To reduce the likelihood of encountering this issue, Baxter is asking customers to contact Baxter Technical Assistance at 800-356-3454 in advance of making changes to their network or server infrastructure supporting the pumps or the Baxter Gateway. Changes requiring prior notice can be found in the Urgent Medical Device Correction communication and in Baxter’s Gateway Server Installation Handoff document, which customers receive upon installation. Additionally, Baxter recommends that customers ensure backup devices are readily available when infusing critical medications. Product Code Product Description Serial Numbers 3570009 Spectrum IQ Infusion System with Dose IQ Safety Software All Customers with additional questions can contact their Baxter sales representative or Baxter Technical Assistance at 800-356-3454 (choose option 1) Monday through Friday between 6 a.m. and 6 p.m. Central Time. Any adverse events experienced with the use of these products may be reported using one of the following options: • Calling Baxter Product Surveillance at 800-437-5176 Monday through Friday between 8 a.m. and 5 p.m. Central Time. • Emailing Baxter at: corporate_product_complaints_round_lake@baxter.com • Reporting to the FDA MedWatch Adverse Event Reporting Program: o Online: By completing and submitting the report online at Online o Regular mail or Fax: Download the form from Download form or call 800-332-1088 to request a reporting form, then complete and mail it to the address on the pre-addressed form, or submit by fax to 800-332-0178. Baxter is voluntarily issuing this Urgent Medical Device Correction with the knowledge of the U.S. Food and Drug Administration. ************************************************************************************ No action is required of local health departments at this time for either of these recalls. If any requests for assistance are received from FDA, the Public Health and Food Protection Program will contact you. For additional information regarding warnings and recalls, please click on the weblink below. ************************************************************************************ For all recalls - http://www.recalls.gov/recent.html


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