Lot Numbers: 609134, 610166, 611100, 612074, 701180, 703021, 704088 706150, 707106, 708503, 709052, 710051, 711074, 711176 801504, 802064, 803116, 805120, 810040, 810150, 812020 902044, 903117, 906039, 907156, 908040, 910558, 912038 1007141

General and Plastic Surgery Devices

2

No

Nationwide Distribution

Churchill Medical Latex-Free IV Start Kit || Product Code: AMS-623ATLF || The kit includes a tourniquet, alcohol prep pads, a PVP ampule swab, 1 3M" Transpore tape roll, 2 gauze sponges, a 3M" Tegaderm" dressing, and a dressing change label || AMS-623ATLF is a convenient kit that aids in preparing the insertion site for the start of intravenous therapy

Lot Number: 1009166

General Hospital and Personal Use Devices

2

No

Nationwide Distribution: USA including states of: CO, IA, OH, MA, MD, MO, NY, FL, SC, FL, and VA.

Churchill Medical 78" Stopcock Extension Set with male/female red cap; || item # AMS-464-1 || Intended use: Intravascular Administration Set

Lot Number: 1010011

General Hospital and Personal Use Devices

2

No

Nationwide Distribution: USA including states of: CO, IA, OH, MA, MD, MO, NY, FL, SC, FL, and VA.

Churchill Medical Systems 14"Extension Set with SmartSite Injection || Item # 43000E || Intended use: Intravascular Administration Set

Lot Number: 1009163

General Hospital and Personal Use Devices

2

No

Nationwide Distribution: USA including states of: CO, IA, OH, MA, MD, MO, NY, FL, SC, FL, and VA.

Churchill Medical Systems 6" Microbore Trifurcated non-DEHP Extension Set with male/Female Luer Locks Slide Clamps & 0.2 Micron Filter || Item Number: AMS-944 || Intended use: Intravascular Administration Set

Lot Number :10J47

General Hospital and Personal Use Devices

2

No

Nationwide Distribution: USA including states of: CO, IA, OH, MA, MD, MO, NY, FL, SC, FL, and VA.

Churchill Medical Systems Central Line and Port Dressing Kit; Item AMS-8295CP-1 || Intended use: Intravascular Administration Set

Lot Number: 10J34

General Hospital and Personal Use Devices

2

No

Nationwide Distribution: USA including states of: CO, IA, OH, MA, MD, MO, NY, FL, SC, FL, and VA.

Churchill Medical Systems Central Line Dressing Kit; || Item # AMS-8316CP-1 || Intended use: Intravascular Administration Set

Lot Number: 1010018

General Hospital and Personal Use Devices

2

No

Nationwide Distribution: USA including states of: CO, IA, OH, MA, MD, MO, NY, FL, SC, FL, and VA.

Churchill Medical Systems Fluid Transfer Set; Sterile || Item # AMS-451 || Intended use: Intravascular Administration Set

Product Code AMS-8172CP-5 -- lots 10J15, 10K09, 10K19, 11A77, 11C103, 11D79, 11F66, 11H18, 11J41, and 11L54.

General Hospital and Personal Use Devices

2

No

Nationwide Distribution including AZ, CA, DE, FL, IL, IN, IA, KS, KY, MD, MA, MI, MN, MO, NJ, NY, OH, PA, UT, VA, WA, WV, and WI.

Churchill Medical Systems, Inc. A VYGON COMPANY PICC INSERTION TRAY || Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumens

Product Code AMS-8280CP-4 -- lots 10K16, 10L20, 11A78, 11B24, 11B16, 11C70, and 11D14.

General Hospital and Personal Use Devices

2

No

Nationwide Distribution including AZ, CA, DE, FL, IL, IN, IA, KS, KY, MD, MA, MI, MN, MO, NJ, NY, OH, PA, UT, VA, WA, WV, and WI.

Churchill Medical Systems, Inc. A VYGON Company PICC INSERTION TRAY Kit || Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumens

Product Code AMS-9848CP-11 -- lots 10J80 and 10K62.

General Hospital and Personal Use Devices

2

No

Nationwide Distribution including AZ, CA, DE, FL, IL, IN, IA, KS, KY, MD, MA, MI, MN, MO, NJ, NY, OH, PA, UT, VA, WA, WV, and WI.

Churchill Medical Systems, Inc. A VYGON Company PICC LINE TRAY Kit || Prefilled syringes included in the tray kit are used to maintain the patency of indwelling catheter lumens

Product Code AMS-7091CP - lot 11C119.

General Hospital and Personal Use Devices

2

No

Nationwide Distribution including AZ, CA, DE, FL, IL, IN, IA, KS, KY, MD, MA, MI, MN, MO, NJ, NY, OH, PA, UT, VA, WA, WV, and WI.

Churchill Medical Systems, Inc. DRESSING CHANGE KIT || Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumens

Product Code AMS-9889CP-7 -- lot 10I86.

General Hospital and Personal Use Devices

2

No

Nationwide Distribution including AZ, CA, DE, FL, IL, IN, IA, KS, KY, MD, MA, MI, MN, MO, NJ, NY, OH, PA, UT, VA, WA, WV, and WI.

Churchill Medical Systems, Inc. PORT-A-CATH Tray Kit || Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumens

Product Code AMS-8522CP-3 - lot 10K50.

General Hospital and Personal Use Devices

2

No

Nationwide Distribution including AZ, CA, DE, FL, IL, IN, IA, KS, KY, MD, MA, MI, MN, MO, NJ, NY, OH, PA, UT, VA, WA, WV, and WI.

Churchill Medical Systems, Inc. VAD ACCESS TRAY Kit || Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumens

Product Code AMS-9437CP -- lots 1112059, 1112106, 1202101, 1101505, 1101026, 1103020, 1104130, 1103190, and 1109064.

General Hospital and Personal Use Devices

2

No

Nationwide Distribution including AZ, CA, DE, FL, IL, IN, IA, KS, KY, MD, MA, MI, MN, MO, NJ, NY, OH, PA, UT, VA, WA, WV, and WI.

Churchill Medical Systems, Inc. VAD ACCESS TRAY Kit || Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumens

Lot Number: 1010004

General Hospital and Personal Use Devices

2

No

Nationwide Distribution: USA including states of: CO, IA, OH, MA, MD, MO, NY, FL, SC, FL, and VA.

Churchill Medical Systems LifeGuard Non-Coring Huber Needle, Lifeguard Non-Coring Safety Infusion Set 22GA, 3/4"; Item # CLG-2234 || The Lifeguard

Lot Number: 1010066

General Hospital and Personal Use Devices

2

No

Nationwide Distribution: USA including states of: CO, IA, OH, MA, MD, MO, NY, FL, SC, FL, and VA.

FMI 105"Oral Surgery Administration Set; || Item AMS-468-1 || Manufactured For: First Medical inc., 8515 Douglas Ave., Suite 23 Urbandale, IA 50322 || Intended use: Intravascular Administration Set

Lot Number: 1706049D

General Hospital and Personal Use Devices

2

No

U.S.

19Ga x 1 Huber Needle Set. Product Code: MBS-1910.

Lot #1210099

General Hospital and Personal Use Devices

2

No

Nationwide Distribution including MO, IL, FL, PA, VA, MO, NY, NE, NH, and OH.

Lifeguard Infusion Set with Smartsite, 20Ga, 1, CLGY-2010 || Huber type needle set used for the infusion of medical fluids into implantable ports.

Lot Numbers: 17F001D & 17K038D UDI: 08498840004814

General Hospital and Personal Use Devices

2

No

Nationwide Distribution to states of: AZ, UT, WI, NJ, CT, TX, PA, VA, MN, MA, MO, FL, and CA.

Maximum Barrier Insertion Tray, Product Code: AMS-9152CP || Convenience kit for the insertion of PICCs into the vascular system.

Lot Numbers: 16I025D, 16L026D, 17C014D UDI: 08498840009604

General Hospital and Personal Use Devices

2

No

Nationwide Distribution to states of: AZ, UT, WI, NJ, CT, TX, PA, VA, MN, MA, MO, FL, and CA.

Maximum Barrier Tray, Product Code: MCITX-1 || Convenience kit for the insertion of PICCs into the vascular system.

Lot Number: 17I024D UDI: 08498840010068

General Hospital and Personal Use Devices

2

No

Nationwide Distribution to states of: AZ, UT, WI, NJ, CT, TX, PA, VA, MN, MA, MO, FL, and CA.

Maximum Barrier Tray, Product Code: AMS-9018CP || Convenience kit for the insertion of PICCs into the vascular system.

Lot Number: 17C060D UDI: 08498840010563

General Hospital and Personal Use Devices

2

No

Nationwide Distribution to states of: AZ, UT, WI, NJ, CT, TX, PA, VA, MN, MA, MO, FL, and CA.

Neonatal PICC Tray, Product Code: AMS-8010CP-1 || Convenience kit for the insertion of PICCs into the vascular system.

Lot Number: 1705060D

General Hospital and Personal Use Devices

2

No

U.S.

Nutrisafe 2 35 mL Syringe for Safety Connection. Product Code: 1015.352M

Lot Numbers: 910118 Exp: 2014/10

Gastroenterology-Urology Devices

2

No

Nationwide Distribution -- CA, NM, NJ, NY, PA, VA, and TX.

Vygon Nutrisafe 2 syringe 5 ml, For Oral use only with Nutrisafe 2 || Product Code: 1015.062M || Vygon/Churchill Medical System

Lot Numbers:   910107, Exp: 2014/11  911165, Exp. 2014/12

Gastroenterology-Urology Devices

2

No

Nationwide Distribution -- CA, NM, NJ, NY, PA, VA, and TX.

Vygon Nutrisafe 2 syringe 10 ml, Syringe for connection to Nutrisafe 2. For oral use only || Product Code: 1015.122M || Vygon/Churchill Medical System