DeRoyal Industries Inc

a) REF 47-763.04, Lot Numbers:42728139, 42812373 b) REF 47-763.06, Lot Numbers:43638080, 44508341 c) REF 47-763.07, Lot Number:44877040 d) REF 89-6752.01, Lot Numbers:43183812, 43959220, 44484561, 44514919 e) REF 89-6818.02, Lot Numbers:42054787, 42691241, 43197966, 43979458 f) REF 89-7212.04, Lot Numbers:41684621, 41957423, 42302605, 42623281, 42699622, 42982612, 43253681, 43504920, 43793400, 44094150, 44543787, 45017543 g) REF 89-7212.05, Lot Number:45456132

General and Plastic Surgery Devices

2

No

US Nationwide distribution in the states of GA, IN, FL, and PA

DeRoyal Sterile Custom kits containing Medline Aplicare Povidone Iodine Prep Pads: || a) Incision and Drainage Tray, REF 47-763.04 || b) Incision and Drainage Tray, REF 47-763.06 || c) Incision and Drainage Tray, REF 47-763.07 || d) Cricothyreotomy Ambulance Kit, REF 89-6752.01 || e) Incision and Drainage Tray, REF 89-6818.02 || f) Plastic Pack, REF 89-7212.04 || g) Plastic Pack, REF 89-7212.05 || Product Usage: || Custom surgical and procedural kits

Ref 89-7859.01: Lot numbers: 27369748, 27469087, 27964707, 28167081, 28207599, 28712544;  Ref 89-7859.02: Lot numbers: 35947501, 35550352, 38844461 Ref 89-7750.02: Lot numbers: 29929171, 30474952 Ref 89-7750.03: Lot numbers: 30984021, 31210924 Ref 89-8514.02: Lot numbers: 37392319, 37078506, 37109721, 36974376, 37057289, 36813530, 37086725, 37099609, 37253124, 37325378, 37401318, 37413132 Ref 89-5792.10: Lot numbers: 39821181, 39507167, 39072116, 39863866 Ref 89-7626.02: Lot numbers: 36068496, 359097163, 35543822, 35328356, 35428242, 35549693, 34939471, 33091009, 34952712 Ref 89-7626.03: Lot numbers: 39301960, 36660692, 37008882, 37210095, 37915491, 37217991, 40101164, 37519742, 38455852, 38756495, 39417057, 39714051, 39913835 Ref 89-8440.01: Lot numbers: 36674648, 36612412 Ref 89-8440.02: Lot number: 36987476

General and Plastic Surgery Devices

2

No

Distributed in MO, MA, NC, CT, Kuwait.

DeRoyal sterile custom surgical kits: || 1) Emergency CABG Pack Pgybk, ref 89-7859.01 || 2) Emergency CABG Pack Pgybk, ref 89-7859.02 || 3) Open Heart Pack A&B; Pgybk, ref 89-7750.02 || 4) Open Heart Pack A&B; Pgybk, ref 89-7750.03 || 5) Intl-Cardiac Surgery Pack A&B; Pgybk, ref 89-8514.02 || GEO-MED sterile custom surgical kits: || 1) Open Heart Pack Pgybk, ref 89-5792.10 || 2) Open Heart A&B; Pgybk, ref 89-7626.02 || 3) Open Heart A&B; Pgybk, ref 89-7626.03 || 4) Open Heat Pack A&B; Pgybk, ref 89-8440.01 || 5) Open Heart Pack A&B; Pgybk, ref 89-8440.02

Lot Numbers: 39098746, 39655101, 39985370, 40067795

General Hospital and Personal Use Devices

2

No

Distributed in the states of VA, AL, FL, and CA.

HYDRO-TEMP(R) Neonatal Temperature Skin Sensor, REF HNICU-32, 50 units per box, NON STERILE, Rx only.

Lot Number 22622679

General Hospital and Personal Use Devices

2

No

Nationwide

NOVAPLUS (TM), SUCTION CANISTER, 1200cc, RIGID, WITH ELBOW, Cat. No. V71-3001, Rx only, NON-STERILE, Made exclusively for Novation by DeRoyal, 200 DeBusk Lane, Powell, TN 37849 || Most commonly used during medical medical emergencies and surgery to remove fluid and secretions from a patient.

Lot numbers: 08150012, 08156012, 08179012, 08172012, 08221012, 08207012, 08247012, 08249012, 08302012, 08270012, 08310012, 08312012, 08354012, 09022012, and 08354012

General and Plastic Surgery Devices

2

No

LA & MS

DeRoyal TOTAL HIP TRACECART, REF 53-1820.14, Rx ONLY, NON-STERILE. Custom surgical kit containing Stryker CBCII Blood Conservation Kit.