FDA Recalls – May

FDA Recalls

Company: Smith's Medical ASD, Inc. PRODuCTS: BCI Remote Alarm Cables (NO=Normally Open, NC=Normally Closed), used with 9004 the Capnocheck Capnography (Plus or Sleep) System

Reorder numbers: WW3398NO & WW3398NC

Recall Class: Class I

Date Recall Initiated: February 6, 2013

Lot Numbers: WW3398NO0820, WW3398NO0847, WW3398NO0948, WW3398NC0822, WW3398NC0847, and WW3398NC0947.

These cables were distributed in Colorado, Illinois, Indiana, Massachusetts, South Carolina, and Wisconsin from October, 2008 through September, 2012.

Use: The BCI Remote Alarm Cables are designed for use with the 9004 Capnocheck Capnography (Plus or Sleep) System to transfer alarm signals from the Capnocheck Capnography System to a remote alarm system.

The BCI Remote Alarm Cables and the 9004 Capnocheck Capnography System are intended for use in all critical environments including ventilator applications, patient transport, and anesthesia on patients ranging from pediatric to adult.

Recalling Firm:
Smiths Medical ASD, Inc.
1265 Grey Fox Rd
Saint Paul, Minnesota 55112-6929

Reason for recall: Smiths Medical has become aware that, in rare instances, the BCI Remote Alarm Cables (BCI Cables) are not transferring alarms when used with some remote nurse alarm systems. These products may cause serious adverse health consequences, including death.

Public Contact: Customers may contact the firm’s Medical's Customer Service Department at 1-800-2585361.

FDA District: Minneapolis District Office

FDA Comments: On Feb. 6, 2013, Smiths Medical sent its customers an "Urgent Medical Device Field Safety Notice-Recall" letter by UPS. The letter described the affected product, problem and actions to be taken.

Customers were instructed to: inspect their inventory remove all affected devices from use complete and return the attached "Confirmation Form" by fax at 1-800-237-8033 or by email to BCIRemote.AlarmCable@smiths-medical.com.

The letter stated that a Customer representative will contact customers with instructions for returning the affected products for replacement or credit. For questions, contact Smiths Medical's Customer Service Department at 1-800-258-5361.

 

Company: Animas Corporation PRODuCT: 2020 Insulin Infusion Pump

Recall Class: Class I

Date Recall Initiated: January 3, 2013

Lot Numbers: All lots manufactured from March 1, 2012 to November 30, 2012. Manufacturing and Distribution DATES: The affected products were manufactured from March 1, 2012 to November 30, 2012 and distributed from March 1, 2012 to September 30, 2012.

Use: The Animas 2020 Insulin Pumps are used to deliver insulin directly into your blood for the treatment of diabetes.

Recalling Firm:
Animas Corporation
200 Lawrence Dr.
West Chester, PA 19380-3428

Reason for recall: Animas has identified a component issue affecting Animas(R) 2020 Infusion Insulin
Pumps manufactured from March 1, 2012 to November 30, 2012. The component issue may trigger the pumps to sound a false alarm or warning related to one of the following:

  • “Loss of prime”
  • “Occlusion”
  • “No Cartridge detected”

If you receive any of these alarms, the pump may prompt you to complete the rewind, load and prime sequence to clear this alarm. Failure to follow the pump’s safety instructions and disconnect your infusion set from your body before the “rewind, load and prime” steps can lead to unintended delivery of insulin, placing you in danger of potential serious health risks, such as hypoglycemia.

Users should follow the safety instructions in your Animas Owner’s Booklet and ALWAYS disconnect the infusion set from your body when:

  • Rewinding the motor
  • Loading the cartridge
  • Priming the infusion set

The Animas 2020 Insulin Pump also has a software limitation that will impact the ability of the pump to function past December 31, 2015. After this date, the pump will no linger deliver insulin and will generate a “Call Service Alarm.”

This product may cause serious adverse health consequences, including death.

Public Contact: Customers with the device should contact Animas’ Product Fulfillment Center at 877280-2339 between the hours of 6 a.m. and 12 a.m. EST to schedule shipment of your free replacement pump. Customers with technical questions or who want to report a concern should contact Customer Technical Support Center at 866-793-5253.

FDA District: Philadelphia District Office

FDA Comments: Customers who have purchased the affected devices were notified by letter dated January 3, 2013 about the problem. The letter included instructions for customers to contact Animas’ Product Fulfillment Center to schedule shipment of their free replacement pump at 1-877-280-2339 between the hours of 6 a.m. and 12 a.m. Eastern Standard Time.

 

Company: Smiths Medical PRODuCT: Spacelabs BleaseSirius Anesthesia Workstation, BleaseFocus Anesthesia Workstation, and CAS I/II Absorber contained in Service Kits Part Number 12200902, 0500659-00, and 050-0901-00, and any workstation installed with the CAS I/II Absorber.

These products were manufactured and distributed from Oct. 31, 2012 to Jan. 15, 2013.

Recall Class: Class I

Date Recall Initiated: Jan. 15, 2013

Use: These products are used in the hospital environment and in locations not requiring mobility of the products. They provide respiratory support to deliver oxygen, air, and nitrous oxide in a controlled manner to various patient-breathing circuits with or without the use of a mechanical ventilator, and may be used to deliver anesthetic vapor.

Recalling Firm: Spacelabs Healthcare, Inc. 5150 220th Ave SE Issaquah, Washington 98029-6834

Manufacturer: Del Mar Reynolds Medical, Ltd. 1-2 Harforde Ct., Foxholes, Business Park Hertford, United Kingdom

Reason for recall: There is a defect in CAS I/II Absorbers in the Spacelabs Anesthesia Workstations and Service Kits that may cause a condition leading to an increase in the carbon dioxide concentration within the inhaled gas being delivered to the patient. This product may cause serious adverse health consequences, including death. Public Contact: Customers with questions about the recall may contact the firm at 1-800522-7025, Select 2 for Technical Support.

FDA District: Seattle District Office

FDA Comments: Spacelabs sent an URGENT-MEDICAL DEVICE CORRECTION letter dated Jan. 16, 2013 to all affected customers. The letter identified the affected product, problem and actions to be taken.

Until a Spacelabs representative replaces the affected product, the letter instructed customers to:
Immediately cease use of BleaseSirius and BleaseFocus Anesthesia Workstations shipped after Oct. 31, 2012.

Immediately cease use of Service Kits Part Number 12200902, 050-0659-00 and 050-0901-00 and any workstation containing a CAS I/II Absorber from a Service Kit.

Advise your staff of this situation. Customers may call Spacelabs Medical at 1-800-5227025 and select 2 for Technical support.

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Healthcare professionals and consumers may report adverse reactions or quality problems they experienced using these products to MEDWATCH: The FDA Safety Information and Adverse Event Reporting Program either online, by regular mail or by FAX.