Lot 6005501, Exp. Date 1/2016

General Hospital and Personal Use Devices

2

No

Nationwide Distribution

HEPFLUSH-10 (HEPARIN LOCK FLUSH SOLUTION, USP) 100 USP units per 10 mL (10 USP units per mL), Single Dose Vial, Rx only -- Fresenius Kabi USA, LLC -- NDC 63323-017-10, Product Code 1710

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.

Serial numbers: 01050741201, 01071198001, 01071198002, 01071198003, 01071198004, 01091136401, 01091136402, 01091136403, 01101314201, 01101322801, 01111505901, 02071228401, 02071228402, 02071228403, 02071228404, 02080975001, 02080975002, 02091137801, 02091149801, 02121713401, 03050791101, 03050804301, 03050804302, 03050804303, 03050804304, 03050804305, 03050804306, 03071247201, 03071247202, 03071247203, 03071247204, 03080984601, 03080984602, 03080984603, 03091161601, 03101347201, 03121742801, 03122862901, 04040581301, 04040581302, 04040581303, 04040581304, 04040581305, 04040581306, 04040581307, 04040581308, 04040581310, 04040581311, 04040581312, 04040581313, 04040581314, 04040586101, 04050810401, 04050810402, 04050810403, 04050810404, 04050810406, 04050810408, 04050810410, 04061028101, 04061028102, 04061028103, 04061028104, 04061028105, 04081009901, 04091187201, 04111563801, 04111568501, 05071272201, 05071272202, 05071272203, 05071272204, 05071272205, 05081019501, 05091197901, 05091197902, 05091201301, 05111513201, 05111576501, 05121762001, 06050840801, 06050840802, 06050840803, 06050840804, 06050840805, 06050840806, 06081037501, 06081039402, 06081039403, 06101394201, 07071320201, 07071320202, 07071328501, 07071328502, 07071328503, 07091223901, 07091223902, 07101410901, 07101415901, 08040660501, 08040660502, 08061090801, 08061090802, 08061090803, 08061090804, 08101430502, 08101439601, 09081073301, 09081074401, 09081076501, 09101453401, 09101457101, 09111641101, 09111641301, 10061121201, 10061121202, 10061121203, 10061121204, 10071396601, 10071396602, 10071396603, 10071396604, 10101463201, 10101464701, 10111652001, 11040710501, 11040710502, 11040710503, 11040710504, 11040710505, 11040710506, 11040710507, 11040710508, 11040710601, 11040710602, 11040710603, 11040710604, 11040710605, 11040710606, 11040710607, 11040710608, 11081101401, 11081105901, 11081113501, 11091285601, 11091285602, 11101475201, 11101476201, 11101476401, 11101477901, 11101478101, 12101495201, 12111677201, 12111686301, 12111686302, 12111688401, 03121734201S, 04040581301A

General Hospital and Personal Use Devices

2

No

Worldwide Distribution - USA (nationwide) and Internationally to Canada.

Penner Patient Stretcher/Transfer Lift System Models 391000-1 and 392000-1 || The Pacific Stretcher/Transfer Lift is used with Whirlpool or Aqua-Aire (air bubbling) bathing system intended for use in nursing homes, hospitals, and assisted living facilities to transfer and/or lift patients under the direct supervision of trained staff. Model 392000-1 is equipped with a scale.

product number CDC-42802-P1A, lot number 23F14A0063

General Hospital and Personal Use Devices

2

No

Nationwide

ARROWg+ard Blue PLUS Pressure Injectable Two-Lumen CVC Kit. The Multiple-Lumen Catheter permits venous access to the central circulation by way of the femoral jugular, or subclavian veins.

Lot No. 68965-1241

General Hospital and Personal Use Devices

2

No

Saudi Arabia and Portugal

Tyvek Pouch/Roll with STERRAD Chemical Indicator, P/N 12425

Lot No. 12056016, 12057027, and 12107105.

General Hospital and Personal Use Devices

2

No

Nationwide Distribution

SmartSite Low Sorbing Infusion Set, Model No. 10015862 || The SmartSite Infusion Sets are used to administer fluid and medications through a needle or catheter inserted into the patient's artery or vein. The set is comprised of components commonly found on intravascular administration sets and extension sets. It includes a SmartSite bag access port, a non-vented drip chamber, roller clamp, infusion pump segment, a male luer, and low sorbing tubing.

Lot Number 3111, Expiration date: 2016/04

General Hospital and Personal Use Devices

1

No

Distributed in the states of MS, ME, GA, and NC.

Puritan absorbent foam tipped applicator; Catalog Number 25-1406 1 PF BT. || Sterile absorbent foam tipped applicator used to apply medication or to obtain specimens from a patient.

All product with USA36A4.4 version of software affected

General Hospital and Personal Use Devices

2

No

Worldwide Distribution - Nationwide Distribution and VA/military/govt consignees and the country of Canada.

BodyGuard 323 pump, models || 100-510PXSI, 100-516PXS, 100-517PXS, 100-518PXS, || 100-603XSA and 100-603XSAP

Part/Catalog number: 0408-830-100 Lot number: 11121171 Expiration date (as printed): 2412-12-01

General Hospital and Personal Use Devices

2

No

Nationwide Distribution including AL, AR, AZ, IA, IL, IN, LA, MA, NC, NE, NM, SC, TN, TX, WI, and WV.

Flyte Togas are components of the Stryker Flyte System and are intended to be worn over any Stryker Flyte Helmet. This toga provides Level 1 and 4 protection according to the Association for the Advancement of Medical Instrumentation (AAMI) Liquid Barrier Performance and Classification System (PB70:2012).

1304035, 1407046, 1410111D

General Hospital and Personal Use Devices

2

No

Nationwide Distribution including TX, OH, NY, CA, UT, PA, MA, NY, VA, and IL.

6" Trifurcated Extension Set, Product Code: AMS-375-1 || Accessory device used to administer medical fluids

1311080

General Hospital and Personal Use Devices

2

No

Nationwide Distribution including TX, OH, NY, CA, UT, PA, MA, NY, VA, and IL.

Bifircated Extension Set, Product Code: BN-828 || Accessory device used to administer medical fluids

1303123 1305003 1305008 1305049 1306097

General Hospital and Personal Use Devices

2

No

Nationwide Distribution including TX, OH, NY, CA, UT, PA, MA, NY, VA, and IL.

4" Microbore Double Lumen Set with Bionector, Product Code: BN-208 || Accessory device used to administer medical fluids

1303120 1305002 1306099

General Hospital and Personal Use Devices

2

No

Nationwide Distribution including TX, OH, NY, CA, UT, PA, MA, NY, VA, and IL.

4" Microbore Trifurcated Ext set, Product Code: BN-308 || Accessory device used to administer medical fluids

1303181 1303100 1304183

General Hospital and Personal Use Devices

2

No

Nationwide Distribution including TX, OH, NY, CA, UT, PA, MA, NY, VA, and IL.

4" Microbore T-Port Set, Product Code: BN-448 || Accessory device used to administer medical fluids

1304129 1305051

General Hospital and Personal Use Devices

2

No

Nationwide Distribution including TX, OH, NY, CA, UT, PA, MA, NY, VA, and IL.

8" Standard Bore Ext Set, Product Code: BN-481 || Accessory device used to administer medical fluids

1303184 1304184 1305112 1306088 1309061 1311057 1312168 1401125 1402017 1403050 1404052 1405018 1405106 1406151 1407065 1408054 1409122D 1410064D 1410155D 1410156D

General Hospital and Personal Use Devices

2

No

Nationwide Distribution including TX, OH, NY, CA, UT, PA, MA, NY, VA, and IL.

7" High Pressure Set with Bionector, Product Code: CMS-808 and CMS-808-1 || Accessory device used to administer medical fluids

1311028 1311040 1311041 1407066 1407197 1408055 1409055D 1410048D 1410157D

General Hospital and Personal Use Devices

2

No

Nationwide Distribution including TX, OH, NY, CA, UT, PA, MA, NY, VA, and IL.

7" Standard Bore High Pressure Ext Set, Product Code: CMS-809 || Accessory device used to administer medical fluids

1303119 1305010 1306098 1305005

General Hospital and Personal Use Devices

2

No

Nationwide Distribution including TX, OH, NY, CA, UT, PA, MA, NY, VA, and IL.

Bifurcated set with check vales and Bionectors, Product Code: BN-2082CV || Accessory device used to administer medical fluids

1303121 1305004 1304149 1305011 1306100 1303122 1304003 1305007 1305006 1305012 1306101

General Hospital and Personal Use Devices

2

No

Nationwide Distribution including TX, OH, NY, CA, UT, PA, MA, NY, VA, and IL.

4" Trifurcated set with Bionectors and check valves, Product Code: BN-3082CV and BN-3083CV || Accessory device used to administer medical fluids

1310051 1312063

General Hospital and Personal Use Devices

2

No

Nationwide Distribution including TX, OH, NY, CA, UT, PA, MA, NY, VA, and IL.

6" Trifurcated set with Bionectors, Product Code: BN-944 || Accessory device used to administer medical fluids

(NOTE: The listed serial numbers are for the carts manufactured and include those that were distributed.)   1) Part Number: 31113.801; Serial Numbers: 1306000, 1306007, 1306014, 1306021, 1306103, 1306001, 1306008, 1306015, 1306022, 1306104, 1306002, 1306009, 1306016, 1306023, 1306105, 1306003, 1306010, 1306017, 1306024, 1307100, 1306004, 1306011, 1306018, 1306100,  1307101, 1306005, 1306012, 1306019, 1306101, 1307102, 1306006, 1306013, 1306020, 1306102, 1317103.   2) Part Number: 31113.701; Serial Numbers: 11001, 11011, 11020, 11030, 11039, 11048, 11058, 11002, 11012, 11021, 11031, 11040, 11049, 11059, 11003, 11013, 11023, 11032, 11041, 11050, 11060, 11005, 11014, 11024, 11033, 11042, 11051, 11061, 11006, 11015, 11025, 11034, 11043, 11052, 11063, 11007, 11016, 11026, 11035, 11044, 11053, 11064, 11008, 11017, 11027, 11036, 11045, 11055, 11065, 11009, 11018, 11028, 11037, 11046, 11056, 11066, 11010, 11019, 11029, 11038, 11047, 11057, 11067.

General Hospital and Personal Use Devices

1

No

Nationwide

The I-Cart is used to store, transport, and power video equipment used in medical procedures.

21-7001-24: Lots 14X297 and 14X323 21-7301-24 (Flow Stop): Lot 14X324

General Hospital and Personal Use Devices

2

No

Worldwide Distribution - US (nationwide) Distribution to the states of : AL, AZ, AR, CA, CO, CT, FL, GA, HI, IL IN, IA, MD, MA, MN, MS, MO, NE, NV, NH ,NJ, NM, NY, NC, OH, OR, PA, SD, TN, TX, UT, VA and WA., and to the countries of : Arab Emirates, Austria, Australia, Belgium, Canada, Switzerland, Colombia, Czech Republic, Germany, Denmark, Spain. Finland, France, United Kingdom (GB) Hungary, Indonesia, Ireland, Italy, Netherlands, Portugal, Sweden, Singapore and South Africa.

CADD" Medication Cassette Reservoir, 50mL, REF 21-7001-24 & 21-7301-24, Sterile EO, Rx only.

Medtronic MiniMed CareLink Pro 4.0 model MMT-7335WWP and Clinical model MMT-7334

General Hospital and Personal Use Devices

2

No

Worldwide Distribution to Japan only. CareLink Clinical is for clinical trials only (US and International)

CareLink Pro || Medtronic CareLink Pro MMT-7335 is a personal computer software application designed to enhance Health Care Provider management of diabetic patients using Medtronic insulin pumps and blood glucose meters. MMT-7335 is intended for use by Health Care Providers/Physicians as a therapy management accessory to: || - read and store history and settings data supported insulin pump models and supported blood glucose meters || - read and report user-programmable settings on supported pump models || - read device data from the CareLink Online system || - write new device data to the CareLink system || - generate reports from the patient records for use in managing the patient's therapy. || CareLink Clinical || Medtronic CareLink MMT-7334 is a network based software system residing on a computer server platform connected to the Internet. The system is designed to upload patient data from Medtronic MiniMed insulin pumps and supported third-party blood glucose meters to the MMT-7334 central database via a client PC (Personal Computer), which connects to supported devices. The data contained in MMT-7334 is accessible to users using a standard browser, i.e. Microsoft Internet Explorer, on a PC that is connected to the Internet. The user may view and print various reports generated from the device data uploaded to MMT-7334, plus additional information provided by the user. The product does not provide any medical advice to patients or physicians. This is currently only intended to be used in Clinical Trials. || Both products are CD ROMs.

NTL-30 G0556, G0561, G0572, G0585, G0593, G0601, G0610, G0614, G0622, G0634, G0644, G0649, G0653, G0662, G0667, G0672, G0683, G0684, G0685, G0698, G0705, G0708, G0711, G0712, G0714, G0716, G0723, G0719, G0726, G0734, G0744, G0750, G0752, G0760  NTL-60 G0554, G0566, G0578, G0594, G0598, G0612, G0615, G0623, G0626, G0636, G0639, G0650, G0657, G0658, G0659, G0665, G0668, G0670, G0671, G0673, G0679, G0680, G0686, G0687, G0691, G0699, G0703, G0706, G0709, G0715, G0722, G0725, G0729, G0735, G0739, G0741, G0745, G0751, G0756, G0761  TL-INT-60 G0563, G0565, G0577, G0663, G0701, G0710, G0713, G0733, G0737, G0753  INT-60 G0555, G0567, G0575, G0587, G0591, G0603, G0620, G0638, G0640, G0648, G0664, G0690, G0718, G0746  NGF-60 G0550, G0560, G0568, G0576, G0592, G0609, G0628, G0646, G0655, G0675, G0688, G0697, G0707, G0724, G0730, G0728, G0743, G0754

General Hospital and Personal Use Devices

2

No

Nationwide Distribution.

- NTL-30 30ml Nutrio Enteral Feeding Syringe (sterile) || - NTL-60 60ml Nutrio Enteral Feeding Syringe (sterile) || - TL-INT-60 60ml Nutrio Enteral Feeding Syringe with Twistlok adapter (sterile) || - INT-60 60mL Nutrio Intopo Enteral Feeding Syringe (sterile) || - NGF-60 60ml Nutrio GraviFeed Syringe (sterile) || The Enteral Syringe consists of a calibrated hollow cylindrical body and movable plunger. At the tip of the barrel is an oral lock connector. Product is considered sterile.

Part Number: 4513C or 4513-1.  Lot Number: 2014030110

General Hospital and Personal Use Devices

2

No

Worldwide distribution. US Nationwide, Canada, Australia, Netherlands, Switzerland, Japan,

Outer cardboard box labeling: || Pinnacle Cure Sleeve, Curing Light Tip Sleeves. || Kerr Total Care. || Part Number: 4513C or 4513-1 || Single Patient Use || Fits 13mm Tips. Pack of 400. || Metrex Research, Manufacturer. || Inner individual packaging of each sleeve: || Cure Sleeve by Pinnacle || Model 4500