Device Recall Baxter

product code 2C1071KJP, lot 10H054 and product code 2C1073KJP, lot 10H054

General Hospital and Personal Use Devices

2

No

Worldwide Distribution - USA including AL and the countries of Mexico and Spain

Baxter Single Day Infusor 2 mL/h Portable Elastomeric Infusion System; an Rx sterile disposable drug delivery system; Baxter Healthcare Corporation, Deerfield, IL 60015; REF 2C1071KJP || The Infusor device is indicated for patients requiring slow, continuous intravenous, intra-arterial, epidural, or subcutaneous administration of medications.

Serial numbers 6100410FA, 8110687FA and 11021746FA

General Hospital and Personal Use Devices

2

No

Puerto Rico

Baxter Flo-Gard 6201, Single Channel Volumetric Infusion Pump; Baxter Healthcare Corporation, Deerfield, IL 60015; Product Code # 2M8063 || The Flo-Gard Volumetric Infusion Pumps are an electromechanical pump used for intravenous infusion of fluids at user-selected rates.

Product Code H93869100, Lot 1001380 and Product Code H93866100, Lot 1001365

General Hospital and Personal Use Devices

1

No

Worldwide Distribution - US Distribution to the states of UT, TX, and IL, and to the countries Austria, Germany, Spain, Switzerland, and Netherlands. No VA/military/govt consignees.

Self-Righting Luer Lock Tip Cap, Green and Self-Righting Luer Slip Tip Cap, Yellow, Baxter Healthcare Corporation, 14445 Grasslands Dr. Englewood, CO 80112 USA. DISCPAC Syringe Tip Caps. RER H93866100 x 1000. Sterile

All DiscPac products are affected within expiry up to October 2017

General Hospital and Personal Use Devices

1

No

Nationwide Distribution

Baxter, Self-Righting Syringe Tip Caps, Self-Righting DISCPAC Syringe Tip Caps. Product codes H93866100, H93869100, H93866025, H93867025, H93867100, H938671025, H938671100, H938673025, H938673100, H938674025, H938674100, H938676025, H938676100, H938677025, H938677100, H938679025, H938679100, H938690025, H93869025, H938693025, H938696025, H93868025, H93868100, H938672025, H938672100, H938675025, H938675100, H938678025, and H938678100.

All HomeChoice and HomeChoice PRO devices. All LOT numbers and Serial number for Product Codes 5C4471, 5C4471R, 5C8310 and 5C8310R.   Dates Distributed: 1994 to present  Quantity Distributed: All

Gastroenterology-Urology Devices

2

No

Nationwide Distribution, District of Columbia, and Puerto Rico.

Baxter HomeChoice and HomeChoice Pro APD systems, designed to provide Automated Peritoneal Dialysis (APD) therapy for pediatric and adult renal patients.