Brand Name: Basal/Bolus Infusor. Indicated for the intravenous administration of medications. Class II

Reason: Baxter Healthcare Corporation (Baxter) is issuing an Urgent Product Recall for the products listed above due to an increase in rupture complaints. Baxter has implemented product and process improvements which have substantially improved product quality. Complaint rates for ruptures have since decreased. Baxter wants to ensure that no affected product remains in the field.

Baxter Healthcare Corp. 20130607 Terminated
Distributed: Distributed Nationwide and in Puerto Rico.
Brand Name: SV Elastomeric Infusion Device. Indicated for the intravenous administration of medications. Class II

Reason: Baxter Healthcare Corporation (Baxter) is issuing an Urgent Product Recall for the products listed above due to an increase in rupture complaints. Baxter has implemented product and process improvements which have substantially improved product quality. Complaint rates for ruptures have since decreased. Baxter wants to ensure that no affected product remains in the field.

Baxter Healthcare Corp. 20130607 Terminated
Distributed: Distributed Nationwide and in Puerto Rico.
Brand Name: Intermate Infusion Pump. Indicated for the intravenous administration of medications. Class II

Reason: Baxter Healthcare Corporation (Baxter) is issuing an Urgent Product Recall for the products listed above due to an increase in rupture complaints. Baxter has implemented product and process improvements which have substantially improved product quality. Complaint rates for ruptures have since decreased. Baxter wants to ensure that no affected product remains in the field.

Baxter Healthcare Corp. 20130607 Terminated
Distributed: Distributed Nationwide and in Puerto Rico.
Brand Name: Intermate Infusion Pump. Indicated for the intravenous administration of medications. Class II

Reason: Baxter Healthcare Corporation (Baxter) is issuing an Urgent Product Recall for the products listed above due to an increase in rupture complaints. Baxter has implemented product and process improvements which have substantially improved product quality. Complaint rates for ruptures have since decreased. Baxter wants to ensure that no affected product remains in the field.

Baxter Healthcare Corp. 20130607 Terminated
Distributed: Distributed Nationwide and in Puerto Rico.
Brand Name: Regional Analgesia Infusor System with Patient Control. Indicated for the intravenous administration of medications. Class II

Reason: Baxter Healthcare Corporation (Baxter) is issuing an Urgent Product Recall for the products listed above due to an increase in rupture complaints. Baxter has implemented product and process improvements which have substantially improved product quality. Complaint rates for ruptures have since decreased. Baxter wants to ensure that no affected product remains in the field.

Baxter Healthcare Corp. 20130607 Terminated
Distributed: Distributed Nationwide and in Puerto Rico.
Brand Name: Multirate Infusor Devices. Indicated for the intravenous administration of medications. Class II

Reason: Baxter Healthcare Corporation (Baxter) is issuing an Urgent Product Recall for the products listed above due to an increase in rupture complaints. Baxter has implemented product and process improvements which have substantially improved product quality. Complaint rates for ruptures have since decreased. Baxter wants to ensure that no affected product remains in the field.

Baxter Healthcare Corp. 20130607 Terminated
Distributed: Distributed Nationwide and in Puerto Rico.
Brand Name: Infusor SV and LV Elastomeric Infusion Devices. Indicated for the intravenous administration of medications. Class II

Reason: Baxter Healthcare Corporation (Baxter) is issuing an Urgent Product Recall for the products listed above due to an increase in rupture complaints. Baxter has implemented product and process improvements which have substantially improved product quality. Complaint rates for ruptures have since decreased. Baxter wants to ensure that no affected product remains in the field.

Baxter Healthcare Corp. 20130607 Terminated
Distributed: Distributed Nationwide and in Puerto Rico.
Multilite Dye Handpieces, an optional accessory of the RevLite SI Laser. The Revlite SI laser is intended for General Dermatology, Dermatologic and General Surgical Procedures. Which includes treatments such as tattoo removal, pigmented lesion removal, removal or lightening of hair, skin resurfacing and reduction of red pigmentation in hypertropic and keloid scars The two Multilite Dye Handpieces (HPs) are optional handpieces that can be used with the Revlite SI Laser. Manufactured by: ConBio, A Cynosure Company 47733 Fremont blvd Fremont, CA 94538 Class II

Reason: An inconsistency was identified related to electronic display identification of the optional Multilite Dye Handpieces of the RevLite SI Laser system that may confuse user.

ConBio, a CynoSure Company 20130509 Terminated
Distributed: Worldwide distribution: USA (nationwide) including states of: IL, ME, NM and VA; and countries of: Australia and Chile.
Code Alert Advanced 4-Way Care Solution, CA520 System, PN 9600-1600, RF Technologies. This product is used to alert caregivers when a patient at risk for falls is leaving a bed or chair. Class II

Reason: RF Technologies, Inc. has initiated a recall involving CA520 Code Alert Integrated Care Management Advanced 4-Way Care Solution . Due to a firmware error, the alarm may not be transmitted to the system server immediately.

RF Technologies, Inc. 20130517 Terminated
Distributed: Nationwide Distribution in US including the states of AK, AZ, CA, GA, IA, KY, MT, NE, NJ, ND, and WI.
Quick Connect QLC1677E, QRC1699E, QPC1721E and QFC1683E. STERIS Corporation, Mentor, OH 44060 QLC1677E, QRC1699E, QPC1721E and QFC1683E contain processing instructions, a Quick Reference Wall Chart and a flow unit. The flow unit consists of a Quick Reference Card, tubing, tethers and adapters for connecting specified devices to Flexible Processing Trays/Containers. Class II

Reason: During a routine label review, the firm identified four SYSTEM 1E Quick Connects that will be updated to reflect the removal of obsolete device models. This labeling review process also highlighted the opportunity to combine two existing quick connects into a single product while eliminating the obsolete models.

Steris Corporation 20130304 Terminated
Distributed: Nationwide Distribution including the states of AK, AZ, CA, CO, FL, IL, IN, KY, LA, MA, MD, ME, MI, MO, MS, NC, NE, NH, NY, OH, OK, OR, PA, SD, TN, TX, VA, WA, WI and WY.
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