CDC 34041 VPS Lot# 23F17A0037 23F17B0035

General Hospital and Personal Use Devices

2

Yes

AZ, CA, GA, MA, MO, NY, VA

ARROW¿ PICC || powered by ARROW¿ VPS¿ || Stylet

Catalog #LPS 7255, Lot #20474

General Hospital and Personal Use Devices

2

Yes

FL, GA, LA, MD, NJ, OK, TX, VA

LifePort¿, Dual Lumen Profile Plastic Dual Port with Poly Urethane Catheter Kit, Product Code/REF: LPS 7255, Manufactured by: Horizon Medical Products, Inc., One Horizon Way, P.O. Box 627, Manchester, GA 31816.The devices are placed in a molded PVC tray. The tray is sealed with a Tyvek lid. The inner sealed tray is then placed in another tray, the Instruments for Use (IFU), Patient Information Booklet (PIB), patient ID card and its label, the IFU for the locking mechanism and the labeling describing the materials and priming volume, are all placed on top of that lid before sealing the outer tray with another Tyvek lid. The product label is applied to the outer tray lid and the entire package-tray inside a tray ¿ is then sterilized. The primary sterile barrier is the inner sealed tray.

Lot numbers RF4088610 and RF4088406

General Hospital and Personal Use Devices

2

Yes

The products were shipped to hospitals in AZ, CA, NJ, and WV.

Arrow PICC Kit with Blue Flex Tip Catheter and Placement Wire. Catalog number PK-01552-WSSP

Lot numbers RF4088611 and RF4088128

General Hospital and Personal Use Devices

2

Yes

The products were shipped to hospitals in AZ, CA, NJ, and WV.

Arrow PICC Two Lumen Peripherally Inserted Central Catheter Set with Blue FlexTip Catheter, Seldinger Technique with 130 cm Platinum Tipped Marked Wire. Catalog number PR-05052-LW

Lot number MABY360

General Hospital and Personal Use Devices

2

Yes

The products were shipped to distributors in OH and MO.

Jet Medical 4F x 60cm Single Lumen Polyurethane PICC Nursing Tray. Catalog number JDMPN4S-T

Lot number MABY950

General Hospital and Personal Use Devices

2

Yes

The products were shipped to distributors in OH and MO.

Jet Medical 4F Single Lumen PICC Kit. Catalog number JP7-4

1007398, 1017115, 1018449

General Hospital and Personal Use Devices

2

Yes

DOMESTIC: Nationwide distribution. FOREIGN: Spain, France, Italy, Great Britain, Sweden, Jordan

Vaxcel Implantable Vascular Access System - Titanium Mini Port with 7F Polyurethane Catheter. Boston Scientific Catalog # 45-305, M001453050. Firm on label: Boston Scientific/Medi-Tech, Watertown, MA 02472

1009520, 1009824, 1011813, 1013925, 1018980, 1021339, 1022517, 1022952

General Hospital and Personal Use Devices

2

Yes

DOMESTIC: Nationwide distribution. FOREIGN: Spain, France, Italy, Great Britain, Sweden, Jordan

Silicone Central Venous Catheter with PASV Valve and Polyester Cuff - 6.6F. Boston Scientific Cat. #CVC661IK M001CVC661IK0. Firm on label: Boston Scientific Corporation, NAMIC Technology Center, Glens Falls, NY 12801.

1009522, 1009825, 1012337, 1013926, 1017134, 1017763, 1018161, 1018456, 1022953

General Hospital and Personal Use Devices

2

Yes

DOMESTIC: Nationwide distribution. FOREIGN: Spain, France, Italy, Great Britain, Sweden, Jordan

Silicone Central Venous Catheters with PASV Valve and Polyester Cuff - 7F. Boston Scientific Cat. #CVC702IK, M001CVC702IKO. Firm on label: Boston Scientific *** Manufactured at: 10 Glens Falls Technical Park, Glens Falls, NY 12801.

1011815, 1020902, 1021341, 1021634

General Hospital and Personal Use Devices

2

Yes

DOMESTIC: Nationwide distribution. FOREIGN: Spain, France, Italy, Great Britain, Sweden, Jordan

Implantable Chest Ports labeled: Titanium Single Lumen Port with PASV valve and 6.6F Silicone Catheter. Boston Scientific Cat. # PRTA66P M001PRTA66P0. Firm on label: Boston Scientific Natick, MA and Boston Scientific Corp., Glens Falls, NY.

1012596, 1020903

General Hospital and Personal Use Devices

2

Yes

DOMESTIC: Nationwide distribution. FOREIGN: Spain, France, Italy, Great Britain, Sweden, Jordan

Implantable Chest Ports labeled: Titanium Single Lumen Port with PASV Valve and 6.6F Silicone Catheter. Boston Scientific Cat. # PRTA66A M001PRTA66AO. Firm on label: Boston Scientific, Natick, MA and Boston Scientific, Glens Falls, NY

Lot #: 30938

General Hospital and Personal Use Devices

2

Yes

Worldwide : USA including states of AL, AR, CA, CO, FL, GA, MD, NC, OH, TX, and VT, and countries of Australia, Korea and The Netherlands.

Vortex¿ VX, Port System, 9.6FR, REF/Part Number : P5455K, Catalog Number: P5455, Latex Free, Sterile, AngioDynamics Incorporated, Manchester, GA. 31816

All units.

General Hospital and Personal Use Devices

2

Yes

Nationwide Distribution.

Stryker Custom Cranial Implant Kit, extra large. Distributed by Stryker Craniomaxillofacial, Kalamazoo, MI; Catalog no. 54-00104. || Custom cranial implant designed individually for each patient to correct trauma and/or defects in mandibular, maxillofacial or craniofacial bone.

Part Number: C¿PICSY¿401¿HOPKINS¿0911 00; Global Part Number 13169;   Lot: F2349680.

General Hospital and Personal Use Devices

2

Yes

Worldwide distribution: USA, Chile, Colombia, Panama, Barbados, Canada, Guatemala, and Saudi Arabia.

Peripherally Inserted Central Venous Catheter Tray Silicone, C¿PICSY¿401¿HOPKINS¿0911 00, G13169, 4.0 Fr/60cm, Sterile, Cook Incorporated, 750 Daniels Way, Bloomington, IN 47404 , USA

Part number: PMSY-250-HOPKINS, Global part number: G44036, lot 2308262.

General Hospital and Personal Use Devices

2

Yes

Worldwide distribution: USA, Chile, Colombia, Panama, Barbados, Canada, Guatemala, and Saudi Arabia.

Arterial Pressure Monitoring Tray, 2.5 Fr/ 2.5 cm Polyethylene Catheter,C-PMSY-250-HOPKINS, G44036, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN.

Part number: C-UPICSY-5.0-CT-NT,   Global part number G49163;   Lot numbers: 2266449, 2308713, 2309331.

General Hospital and Personal Use Devices

2

Yes

Worldwide distribution: USA, Chile, Colombia, Panama, Barbados, Canada, Guatemala, and Saudi Arabia.

Turbo-Ject PICC Tray, Power Injectable, Polyurethane Peripherally Inserted Central Venous Catheter, || 5.0 Fr/ 60 cm, UPICSY-5.0-CT-NT, G49163, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN.

Part number: C-UPICSY-5.0-CT-OTW,   Global part number G49164;   Lot numbers: 2263405 and 2277885

General Hospital and Personal Use Devices

2

Yes

Worldwide distribution: USA, Chile, Colombia, Panama, Barbados, Canada, Guatemala, and Saudi Arabia.

Turbo-Ject PICC Tray, Power Injectable, Polyurethane Peripherally Inserted Central Venous Catheter, || 5.0 Fr/ 60 cm, UPICSY-5.0-CT-OTW, G49164, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN.

Part number: C-UPICDSY-5.0-CT,   Global part number G49168;   Lot numbers: 2281646, 2281685, 2312954, 2314026.

General Hospital and Personal Use Devices

2

Yes

Worldwide distribution: USA, Chile, Colombia, Panama, Barbados, Canada, Guatemala, and Saudi Arabia.

Turbo-Ject PICC Tray, Power Injectable, Polyurethane Peripherally Inserted Central Venous Catheter, , || 5.0 Fr/ 60 cm, UPICDSY-5.0-CT, G49168, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN.

Part number: C-UPICDSY-5.0-CT-NT,   Global part number G49169;   Lot numbers: 2244226, 2246219, 2251161, 2255157, 2264598, 2267957, 2267971, 2275435, 2275476, 2278549, 2278570, 2287707, 2287709, 2292788, 2292791, 2298486, 2302064, 2302098, 2306592, 2313790, 2317361, 2317382, 2321273, 2325079, 2327447, 2334833 and 2335156.

General Hospital and Personal Use Devices

2

Yes

Worldwide distribution: USA, Chile, Colombia, Panama, Barbados, Canada, Guatemala, and Saudi Arabia.

Turbo-Ject PICC Tray, Power Injectable, Polyurethane Peripherally Inserted Central Venous Catheter, || 5.0 Fr/ 60 cm, UPICDSY-5.0-CT-NT, G49169, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN.

Part number: C-UPICDSY-5.0-CT-OTW,   Global part number G49170;   Lot numbers: 2242381, 2250288, 2252456, 2255188, 2259981, 2269809 2276836, 2279174, 2282649, 2285530, 2300174, 2305907, 2314025, 2319587 and 2328553.

General Hospital and Personal Use Devices

2

Yes

Worldwide distribution: USA, Chile, Colombia, Panama, Barbados, Canada, Guatemala, and Saudi Arabia.

Turbo-Ject PICC Tray, Power Injectable, Polyurethane Peripherally Inserted Central Venous Catheter, || 5.0 Fr/ 9 cm, UPICDSY-5.0-CT-OTW, G49170, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN.

Part number: C-UPICSY-4.0-CT-NT,   Global part number G49175;   Lot numbers: 2273800, 2334114.

General Hospital and Personal Use Devices

2

Yes

Worldwide distribution: USA, Chile, Colombia, Panama, Barbados, Canada, Guatemala, and Saudi Arabia.

Turbo-Ject PICC Tray, Power Injectable, Polyurethane Peripherally Inserted Central Venous Catheter, || 4.0 Fr/ 60 cm, UPICSY-4.0-CT-NT, G49175, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN.

Part number: C-UPICSY-4.0-CT-OTW   Global part number G49176;   Lot numbers: 2303832

General Hospital and Personal Use Devices

2

Yes

Worldwide distribution: USA, Chile, Colombia, Panama, Barbados, Canada, Guatemala, and Saudi Arabia.

Turbo-Ject PICC Tray, Power Injectable, Polyurethane Peripherally Inserted Central Venous Catheter, , || 4.0 Fr/ 60 cm, UPICSY-4.0-CT-OTW, G49176, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN.

Part number: C-UPICDSY-4.0-CT   Global part number G49180   Lot numbers: 2308697, 2308699, 2308705 and 2309323.

General Hospital and Personal Use Devices

2

Yes

Worldwide distribution: USA, Chile, Colombia, Panama, Barbados, Canada, Guatemala, and Saudi Arabia.

Turbo-Ject PICC Tray, Power Injectable, Polyurethane Peripherally Inserted Central Venous Catheter, || 4.0 Fr/ 60 cm, UPICDSY-4.0-CT, G49180, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN.

Part number: C-UPICDSY-4.0-CT-NT   Global part number G49181   Lot numbers: 2279157, 2309322.

General Hospital and Personal Use Devices

2

Yes

Worldwide distribution: USA, Chile, Colombia, Panama, Barbados, Canada, Guatemala, and Saudi Arabia.

Turbo-Ject PICC Tray, Power Injectable, Polyurethane Peripherally Inserted Central Venous Catheter, || 4.0 Fr/ 60 cm, UPICDSY-4.0-CT-NT, G49181, Sterile, Cook Medical, Cook Incorporated, Bloomington, IN.