Lot Numbers: 903005, 904057, 904060, 904061, 904062, 904063, 905089, 905090, 905091, 906199, 907005, 907006, 907007, 909014, 909015, 909016, 909017, 909018, 909026, 909031, 909032, 909033, 909034, 909035, 909036 and 909037.

General Hospital and Personal Use Devices

2

No

Distributed to Florida.

Churchill Medical Systems Bag Access Device w/Smartsite Needleless Injection Site, Sterile, Non pyrogenic, Latex Free Product Code: KSA-140. Churchill Medical Systems, Inc. Dover, NH 03820. || Intravascular administration set.

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: 1010111

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.

Walkmed Infusion Triton 100" 20 Drop IV Administration Set with Free Flow Protection Clip; Manufactured for: WalkMed Infusion 96 Inverness Drive East, Suite 1 Englewood, CO 80112 || Item # T100-000F || 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

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 :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: 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: 1010034

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.

Winged Infusion Set with 90 degree Huber Needle and Y Injection Site || Distributed By: FloridaInfustion Services, Inc., Palm Harbor, FL 34683 || Item # FIY-2210 || Intended use: Intravascular Administration Set

AMS-623T-6 (1506075D, 1508057D, 1511030D, 1604024D, 1605080D, 1610017D, 1706097D, 1707055D) and AMS-626TGSLF (1601102D, 1603099D, 160581D, 1607019D, 1610057D, 1703068D, 1703069D, 1704065d, 1706076D, 1707031d, 1707056D)

General and Plastic Surgery Devices

2

No

US Distribution.

Vygon IV Start Convenience Kits; Product Codes AMS-623T and AMS-626TGSLF. || Kit used when administering IV during emergency.

Lot Number: 1010030

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.

WalkMed Infusion Triton 90" 20 drop IV Administration Set with 2 Needlefree Y-sites and Back Check Valve; Item # T090-000W || Intended use: Intravascular Administration Set

Lot Numbers: 1010025, 1010067

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.

WalkMed Infusion Triton 90" 20 drop IV Administration Set with Needlefree Y-site || Item # T090-000V || Intended use: Intravascular Administration Set

Lot Number:1010009

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.

WalkMed Infusion Triton 90" 20 drop IV Administration Set with Needlefree Y-site and 0.22 || Intended use: Intravascular Administration Set

Lot Numbers: 1010038, 1010070

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.

WalkMed Infusion Triton 90" 20 drop IV Administration Set; || Manufactured for Walked Infusion 96 Inverness Drive East, Suite 14 Englewood, CO 80112 || Item # T090-000 || 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: 1010111

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.

WalkMed Infusion 100" 20 drop IV Administration Set with 1 Needlefree Y-site and Free Flow Protection Clip || Manufactured for WalkMed Infusion 96 Inverness Drive East Suite 1 Engelwood, CO 80112 || Item # T100-000F || Intended use: Intravascular Administration Set

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: 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

Disposable products

Disposable products

241116FR – 281116FR – 071216FR – 151216FR – 211216FR – 050117FR – 060117FR - 150217FR – 230217FR and 280217FR

1261.153, 1261.203, 1261.206, 1261.207, 1261.208, 1261.306, 6261.203, 6261.206, 6261.306

021214EG, 100315EG, 090615EG, 170615EG

1504XXXX do 1512XXXX 1601XXXX do 1612XXXX

lots 021214EG, 100315EG, 090615EG, 170615EG and 270815EG