NEWS AS OF 1/8/14: Baxter has announced a safety alert for all flexible solution containers that have either a blue or neutral color administration port protector. The safety alert is being issued to provide the following additional instruction which, in some cases, is not included on labeling for these products: do not use a flexible solution container if the administration port protector is not in place prior to use.
The administration port protector serves as a sterility barrier, and is intended to be removed when the set spike is ready to be inserted into the solution port. If a port protector is not in place prior to use, sterility of the administration port may be compromised, potentially placing patients at risk of blood stream infection due to microbial contamination introduced to the fluid path.
For any questions, or to report adverse reactions or quality problems experienced with the use of these products, contact Baxter Corporate Product Surveillance at 1-800-437-5176, or email firstname.lastname@example.org.
NEWS AS OF 12/18/13: Abbott has announced a voluntary recall of 20 lots of FreeStyle and FreeStyle Lite blood glucose test strips sold in the United States. These lots of test strips may produce erroneously low blood glucose results when used with both the FreeStyle blood glucose meter and the FreeStyle Flash blood glucose meter, as well as the OmniPod insulin management system.
When the test strips are used with the newer FreeStyle brand meters, including the FreeStyle Freedom blood glucose meter, FreeStyle Lite blood glucose meter, and FreeStyle Freedom Lite blood glucose meter, the blood glucose test results are not affected. Testing with the FreeStyle InsuLinx blood glucose meter is not affected, as the FreeStyle InsuLinx uses FreeStyle InsuLinx test strips.
The affected test strips are from lots that hold expiration dates from between May 2014 and March 2015. The lot numbers are as follows:
Customers affected by this action are instructed to call Abbott's diabetes care customer service at 1-888-736-9869 for a replacement of the affected test strips at no charge.
NEWS AS OF 12/5/13: Philips is informing customers of a potential hazard associated with the failure of an internal electrical component in the HeartStart FRx, HeartStart Home, and HeartStart OnSite. Philips has found that this component can fail in a way whereby the device may incorrectly indicate that it is ready for use. The probability of an AED experiencing this internal component failure in an emergency situation is extremely low. To date, Philips has received no reports of this failure mode during emergency use. To date, Philips has received no reports of this failure mode during emergency use.
If you ever hear a series of triple chirps from your AED in stand-by mode, contact Philips immediately for delivery of a replacement unit and receipt of a Return Authorization (RA) number. If a series of triple chirps is heard in an emergency situation, press the flashing blue i-button and follow the voice prompts. Removing and reinserting the battery can clear some errors and equip the device to deliver therapy in a rescue. Battery removal and reinsertion should only be done in an emergency situation.
For technical support, contact Philips at 1-800-263-3342 and select option 5.
NEWS AS OF 10/7/13: Graham Field is continuing its recall of the LX3000 Lumex NaviKnee Walker, due to a potential manufacturing defect in the welding of the knee pad aluminum frame tubing. This defect could cause the knee pad to wobble and not be secured in place as required by company specifications. The walkers affected were distributed in January and February of 2013, and bear the serial number LEO290MO0541, and no patient injuries have been reported.
Please contact Graham Field's customer service department at 1-800-347-5678 or e-mail email@example.com for information on returning or disposing of the LX3000 Lumex NaviKnee Walker.
NEWS AS OF 10/7/13: DeRoyal has issued a recall for surgical eye spears (catalog number 30-049). No reason was given for the recall, and the recall only affects eye spears manufactured under lot number 32794811. For further information, DeRoyal's customer service department can be contacted at 1-800-251-9864, or by email at firstname.lastname@example.org.
NEWS AS OF 10/2/13: HemoCue has released an urgent field safety notice regarding the single pack Hb 201 Microcuvettes (catalog number 111715). A production related problem in HemoCue's manufacturing facility has affected some of the package material for single pack Hb 201 microcuvettes within lot numbers 1208655 to 1304738. If a single pack pouch is damaged, the microcuvette can be exposed to moisture, which in some cases many lead to a cuvette not filling or air bubbles being formed. The root cause of the problem has been identified, and the problem has been corrected in the manufacturing process.
The number of affected microcuvettes within the specified lot numbers is low. According to the instructions for use the microcuvette cavity is to be filled completely, and microcuvettes with air bubbles in the optical eye must be discarded. As long as these instructions are followed, measurement performance is not affected and there is no safety risk for the patient.
HemoCue technical support can be contacted at 1-800-426-7256.
NEWS AS OF 8/29/13: Philips Healthcare has released a product advisory regarding their line of HeartStart AEDs. Philips has determined that it is important to clarify information in the Owner's Manual and keep customers informed about the maintenance of the FRx or OnSite HeartStart.
If the FRx or OnSite AED emits a pattern of single chirps, press the blue i-button on the front of the device for information. The AED will tell exactly what actions to take to ensure that the device is ready to use.
If at any time during the life of the device, your FRx or OnSite AED emitted or begins to emit a pattern of triple chirps, it is important that the device be removed from use, and a Philips representative should be contacted. If an FRx or OnSite AED emits a pattern of triple chirps, it is a signal that the device requires investigation by Philips to ensure that it is ready for use. If needed for use in an emergency, make every attempt to clear the error and use the device normally, as described in the Owner's Manual. However, even if the error is cleared, it is important that a Philips representative be contacted to obtain the tools and information needed to ensure that the device is functioning properly. Philips can be reached at 1-800-263-3342, option 6.
Philips has also created a website with additional information about this action. To hear the difference between single chirps and triple chirps emitted by your AEDs, please visit their website at www.philips.com/HeartStartMaintenanceAdvisory.
NEWS AS OF 8/26/13: Philips Respironics has announced that a number of Alice PDx devices (catalog number 1043941) may not remain in the powered-off state after the on/off button has been pressed. In this condition, the device powers back on a few seconds after the button is pressed. This behavior is most likely to occur when a fresh set of non-rechargeable batteries is installed. This condition will not compromise any recorded data or present any harm to a user if it occurs.
This issue only affects Alice PDx devices bearing serial number 16828, shipped between February 15, 2013 and August 19, 2013. Customers who are experiencing this issue are advised to remove the batteries and contact Philips Respironics to arrange for a return of the product. Philips Respironics expects to have the components necessary for repair of the affected devices by September 2, 2013.
Philips Respironics customer service can be contacted at 1-877-387-3311. International customers should call 724-387-4000.
NEWS AS OF 8/20/13: Covidien has announced the voluntary recall of specific lots of their Monoject Prefill Flush Syringes. The affected product numbers are as follows:
- 8881570121 (lot numbers 13A0084N, 13A0094, 13B0364, 13C0504, 13C0514)
- 8881570123 (lot number 13A0084N)
- 8881570125 (lot number 13A0084N)
- 8881580121 (lot number 13A0084N)
- 8881580123 (lot number 13A0084N)
- 8881580125 (lot number 13A0084N)
- 8881590121 (lot number 13A0084N)
- 8881590123 (lot number 13A0084N)
- 8881590125 (lot numbers 13A0084N, 13D0824N
If non-sterile fluid is administered there is a risk of life-threatening infection to the blood stream or other areas. Also, if the clinician uses the Heparin Lock Flush syringe containing only water on peripheral or venous catheters, the potency of the intravascular device may not be maintained and clotting may occur. This could result in non-functional intravenous access requiring the device to be replaced.
The affected product was produced during January through April of 2013. Covidien is unaware of any adverse events associated with the affected product; however, Covidien is requesting that customers quarantine and return any remaining stock of the lots listed above. This recall applies only to product ID and lot numbers listed above. No other lots or product codes of Covidien products are affected by this recall.
Customers who have purchased this product should contact Covidien Customer Service at 1-800-962-9888 for return instructions.
NEWS AS OF 7/24/13: Wheelchairs of Kansas has announced the discontinuation of the Overlander PEVSS/PEVCC wheelchair. The discontinuation is not due to a quality issue, but rather based on a strategic shift in the company overall and increasing demand in other major product lines. Wheelchairs of Kansas will continue to provide service and parts for the Overlander PEVSS/PEVCC wheelchair as outlined in the warranty.
Customers who own an Overlander PEVSS/PEVCS wheelchair can contact Wheelchairs of Kansas at 1-800-537-6454 with any questions regarding their warranty.
NEWS AS OF 7/17/13: Independence Medical is initiating a voluntary recall for all lots of DiaScreen Liquid Urine Controls (catalog number D76004) shipped from facilities located in Twinsburg, OH, Fort Worth, TX, Elgin, IL, and Jacksonville, FL. This recall only impacts DiaScreen Liquid Urine Controls shipped from those four locations.
The recall is due to the discovery that the products may have been stored at temperatures outside of their required storage conditions. Specifically, this refrigerated product may have been exposed to freezing temperatures or stored at normal room temperature, either of which could adversely affect product results. There have been no reports of adverse patient consequences, and the FDA has been notified of this voluntary recall.
Customers who have the affected product in their possession should contact Independence Medical's customer service department at 1-800-860-8027 to arrange for a return.
NEWS AS OF 6/24/13: Baxter Healthcare Corporation has issued an urgent product recall for specific lot numbers of IV solutions in VIAFLEX containers (Baxter product codes 2B0042, 2B0043, 2B0088, 2B0089, 2B0944, 2B0953, 2B0973, 2B1301, 2B1302, 2B1306, 2B1307, 2B1308, 2B1309, and 2B3421). The products released under the specific lot numbers have been identified for potential administration port leakage, a manufacturing issue which occurred during the sealing of the closure assembly at the administration port. This issue has since been resolved.
This recall affects only the lot numbers of products released between February 6, 2012, and May 6, 2013. Customers who have purchased IV solution in VIAFLEX containers should contact Baxter Healthcare Corporation at 1-800-933-0303 as soon as possible to verify if their product is affected by the recall. Affected products should not be used.
NEWS AS OF 6/18/13: Best Sanitizers has reported that three of their products, the HAACP E2 liquid soap (Best Sanitizers catalog number SO10003), the SoftenSure liquid lotion soap bags (Best Sanitizers catalog number SO10022), and the SoftenSure liquid antimicrobial soap bags (Best Sanitizers catalog number SO10023), have been found to contain ingredients which have been placed on California's Prop 65 list. If listed on Prop 65, that ingredient has been identified by the state of California as an ingredient which is known to cause cancer. California is the sole state where this is currently an issue.
While continuing to sell these products is not illegal, beginning June 22nd, 2013, these products can only be sold to users in California if labeled with the appropriate warning. Please contact Best Sanitizers at 1-888-255-3267, extension 126 for assistance in identifying alternative products which do not contain any ingredients listed on Prop 65.
NEWS AS OF 6/4/13: Recent tests of the LX3000 Lumex NaviKnee Walker distributed in January and February of 2013 reflect a potential manufacturing defect in the welding of the knee pad aluminum frame tubing. There is the potential that the frame tubing could break underneath the knee pad. This could cause the knee pad to wobble and not be secured in position as required by company specifications. Please note, no patient injuries have been reported.
In accordance with Graham Field's stringent quality procedures, they have decided to temporarily withdraw this product from distribution. Please contact Graham Field's customer service department at 1-800-347-5678 or e-mail email@example.com for information on returning or disposing of the LX3000 Lumex NaviKnee Walker. Graham Field is working to ensure that future production of this product will meet quality requirements.
NEWS AS OF 5/22/13: Kimberly-Clark has discontinued production on the Child's Face Mask (product code 47127) and replaced it with a new version (product code 32856). The new version has an updated package label and detailed instructions for use, while the design of the mask itself remains unchanged.
The original Child's Face Mask has been distributed in the US for approximately eight years with no reports of an adverse event received by Kimberly-Clark. There is no known risk to health associated with use of the Child's Face Mask in accordance with the information provided on the package label, which includes "Use under adult supervision."
NEWS AS OF 5/14/13: BD has received reports of blood leakage and low draw volume associated with the BD Vacutainer Multiple Sample and Direct Draw Luer Adapter (BD catalog numbers 367290, 368491, and 303380). In a limited number of instances, the gray rubber sleeve on the cannula inside the Vacutainer tube holder has been reported to disengage from the cannula or permit small amounts of blood leakage during the collection of multiple tubes. BD advises any customer who purchased this product to use universal precaution techniques to minimize the risk of blood exposure. BD has implemented corrective actions to eliminate the recurrence of this issue in future lots.
There have also been some reports that blood collection tubes may not fill with the proper volume of blood due to damage to the Luer tip connection of the Adaptor caused in the manufacturing process. As the draw volume is critical for the proper performance of coagulation tubes, decreased blood draw volume might lead to erroneous coagulation assay results, which could potentially impact a physician's treatment decision. BD is working to prevent such damage and has improved their method of detection so that this defect is eliminated. In the interim, please ensure that users of this product look for any evidence of blood leakage at the Luer connection end of the device. If leakage is observed, the following steps should be taken:
- Discard filled tubes since it is possible they will contain less blood volume (Low Draws)
- Replace the Luer Adaptor unit being used with a fresh unit
- Continue to draw blood samples using the fresh unit