Product item number: DYND70800 with Lot Numbers: 13F1, 13KD, 14A1, 14C1, and Lot 1.

General and Plastic Surgery Devices

1

No

Worldwide Distribution - US (nationwide) Distribution including Puerto Rico and to the countries of : United Arab Emirates, Barbados, Bahamas, Chile, Costa Rica, Italy, Lebanon, and Singapore.

Medline Electrical Clipper with Charging base || The Electrical Surgical Clipper is intended for the removal of body hair from patients as required prior to surgery or other minor procedures.

ECVC1010  CVC INSERTION BUNDLE - 3L, 16CM Batch Exp. 2015042150 12/2016 2015061050 01/2017 2015062650 02/2017 2015071050 03/2017 2015081150 03/2017  ECVC1025  16CM CENTRAL LINE BUNDLE  Batch Exp. 2015052750 12/2016 2015062250 01/2017 2015070150 02/2017 2015070950 03/2017 2015080650 03/2017  ECVC1425  20CM CENTRAL LINE BUNDLE  Batch Exp. 2015041450 12/2016 2015052250 12/2016 2015062250 01/2017 2015070150 02/2017  ECVC1780  TRIPLE LUMEN BUNDLE Batch Exp. 2015041450 01/2017 2015081350 05/2017  ECVC1785  QUAD LUMEN BUNDLE Batch Exp. 2015052150 01/2017 2015061850 03/2017  ECVC3015  CVC TRIPLE LUMEN BUNDLE Batch Exp. 2015061050 01/2017 2015061850 01/2017  ECVC3260  CVC INSERT BUNDLE 16CM  Batch Exp. 2015061150 09/2016 2015061550 09/2016  ECVC3540  TRIPLE LUMEN PI CVC BUNDLE  Batch Exp. 2015041350 12/2016  ECVC3575  CVC TRIPLE LUMEN BUNDLE - 20CM  Batch Exp. 2015041550 10/2016 2015061050 01/2017  ECVC3915  VANTEX TLC KIT: CURVED SUTURE NEEDLE  Batch Exp. 2015040850 02/2017 2015042750 02/2017 2015070250 03/2017 2015081150 05/2017  ECVC3925  9F INTRODUCER: CURVED SUTURE NEEDLE Batch Exp. 2015071750 01/2017  ECVC405  CVC MULTI-LUMEN INSERTION BUNDLE  Batch Exp. 2015041750 12/2016 2015061050 01/2017  ECVC4095  AVA HIGH FLOW BUNDLE Batch Exp. 2015060450 08/2016  ECVC4110  MULTI-MED TLC KIT: CURVED SUTURE NDL  Batch Exp. 2015060150 03/2017 2015061550 03/2017 2015080750 04/2017  ECVC4115  6FR INTRODUCER: CURVED SUTURE NEEDLE  Batch Exp. 2015080550 01/2017  ECVC4170  AVA 3xi CVC BUNDLE  Batch Exp. 2015070250 06/2016

General Hospital and Personal Use Devices

2

No

US Distribution in states of: TX, FL, VA, TN, PA, IL, GA, and CA.

Convenience Kits from Centurion that contain an In-Vision- || Plus Needleless IV Connector, Model: code RYM5001 || InVision-Plus¿ Needless IV Connectors are used for single patient use in IV and blood administration sets without the need for needles, thus eliminating the potential for needle-stick injuries during use.

Lot Numbers 122211502  122212515

General Hospital and Personal Use Devices

1

No

Continental U.S.

Medicine Cup, 1 OZ. Liquid medication dispenser to issue a measured amount of liquid medication.

Lot Numbers: 6I26; Unit No: MDS032285; Expiration Date: 08/2019

General Hospital and Personal Use Devices

1

No

Worldwide Distribution - US Nationwide in the states of AL, FL, GA, IA, IL, IN LA, MI, PA, TX, WI, and the country of Canada

Medline E-Z Lubricating Jelly; Bacteriostatic. Water Soluble. Sterile. 2 FL OZ (59 ml). || Product Usage: || For medical purposes to lubricate body orifices to facilitate entry of diagnostic or therapeutic devices. Single use only. Sterile if unopened, undamaged package.

Unit Numbers: NONUNNA3 & NONUNNA4 Lot Numbers: 52581 through 63599

General Hospital and Personal Use Devices

1

No

Worldwide Distribution - USA (nationwide) and to the countries of : Chile, Peru, El Salvador and Taiwan.

Unna-Z, Unna Boot with Zinc and Calamine, Compression Wrap, 1 Per Box, 3-4in x 10yds

Item# MDS9091616T; Lot #132638

Orthopedic Devices

1

No

Nationwide Distribution

16 mm Distraction Pin, Titanium, Qty: 1 per pack; STERILE; Manufactured for: Medline Industries, Inc., Mundelein, IL 60060 USA || Distraction Pin is designed for Anterior Cervical Fusion Procedures. Use with vertebral body distraction instruments. It is intended as a temporary fixation screw utilized during cervical spine procedures.

16 mm Pin: Item# MDS9091212; Lots #136469, 136754 | 18 mm Pin: Item# MDS9091818; Lot #136470

Orthopedic Devices

1

No

Nationwide Distribution

16 mm [or 18 mm] Distraction Pin, Qty: 1 per pack; STERILE; Manufactured for: Medline Industries, Inc., Mundelein, IL 60060 USA || Distraction Pin is designed for Anterior Cervical Fusion Procedures. Use with vertebral body distraction instruments. It is intended as a temporary fixation screw utilized during cervical spine procedures.

Item# MDS9091010; Lots #133115, 136754

Orthopedic Devices

1

No

Nationwide Distribution

10 mm Distraction Pin, Aggressive Qty: 1 per pack; STERILE; Manufactured for: Medline Industries, Inc., Mundelein, IL 60060 USA || Distraction Pin is designed for Anterior Cervical Fusion Procedures. Use with vertebral body distraction instruments. It is intended as a temporary fixation screw utilized during cervical spine procedures.

Item# MDS9091414A; Lots #136190

Orthopedic Devices

1

No

Nationwide Distribution

14 mm Distraction Pin, Exagg Qty: 1 per pack; STERILE; Manufactured for: Medline Industries, Inc., Mundelein, IL 60060 USA || Distraction Pin is designed for Anterior Cervical Fusion Procedures. Use with vertebral body distraction instruments. It is intended as a temporary fixation screw utilized during cervical spine procedures.

Item# MDS9091212B; Lots #136780

Orthopedic Devices

1

No

Nationwide Distribution

12 mm Distraction Pin, Blunt Qty: 1 per pack; STERILE; Manufactured for: Medline Industries, Inc., Mundelein, IL 60060 USA || Distraction Pin is designed for Anterior Cervical Fusion Procedures. Use with vertebral body distraction instruments. It is intended as a temporary fixation screw utilized during cervical spine procedures.

Centurion component code 2841, Affected product was placed into Centurion Convenience Kits between July 2013 and January 2017. Batch Numbers & Exp. dates: 2016100390 12/31/18 2016092190 12/31/18 2016072790 10/31/18 2016061590 4/30/18 2016031490 4/30/18 2016022390 4/30/18 2015111190 4/30/18 2015092890 4/30/18 2015083190 9/30/17 2015032390 10/31/17 2015052890 9/30/17 2015052090 9/30/17 2015050590 9/30/17

General and Plastic Surgery Devices

1

No

US Distribution: NY, NC, PA, CA, OH, WA, VA, NJ, IL

POST-OP EYE TRAY || The Covidien Curity Oval Eye Pads are individually packaged and sterilized by the manufacturer; they are then placed into non-sterile Centurion Convenience Kits along with other || components.

Centurion component code 2841, Affected product was placed into Centurion Convenience Kits between July 2013 and January 2017. Batch Numbers & Exp. dates: 2016081750 4/30/19 2016080450 12/31/18 2016060250 10/31/18 2015091050 4/30/18 2015090350 4/30/18 2015083150 4/30/18 2015012750 10/31/17 2015012250 10/31/17 2014061850 4/30/17

General and Plastic Surgery Devices

1

No

US Distribution: NY, NC, PA, CA, OH, WA, VA, NJ, IL

OPHTHALMIC DRESSING TRAY || The Covidien Curity Oval Eye Pads are individually packaged and sterilized by the manufacturer; they are then placed into non-sterile Centurion Convenience Kits along with other || components.

Centurion component code 2841, Affected product was placed into Centurion Convenience Kits between July 2013 and January 2017. Batch Numbers & Exp. dates: 2016081550 4/30/19 2016080950 4/30/19 2016072250 12/31/18 2016051350 10/31/18 2016030550 4/30/18 2016022350 4/30/18 2016011850 4/30/18 2015122150 4/30/18 2015121450 4/30/18 2015101250 4/30/18 2015070750 2/28/18 2015062950 2/28/18 2015061950 1/31/18 2015062250 2/28/18 2015051850 1/31/18 2015050450 2/28/18 2015042850 11/30/17 2015031950 11/30/17 2015010750 10/31/17 2014103150 7/31/17 2014102750 7/31/17 2014073050 5/31/17

General and Plastic Surgery Devices

1

No

US Distribution: NY, NC, PA, CA, OH, WA, VA, NJ, IL

OPHTHALMIC DRS TRAY || The Covidien Curity Oval Eye Pads are individually packaged and sterilized by the manufacturer; they are then placed into non-sterile Centurion Convenience Kits along with other || components.

Centurion component code 2841, Affected product was placed into Centurion Convenience Kits between July 2013 and January 2017. Batch Numbers & Exp. dates: 2013120690 7/31/18 2013071890 10/31/17

General and Plastic Surgery Devices

1

No

US Distribution: NY, NC, PA, CA, OH, WA, VA, NJ, IL

EYE KIT || The Covidien Curity Oval Eye Pads are individually packaged and sterilized by the manufacturer; they are then placed into non-sterile Centurion Convenience Kits along with other || components.

Centurion component code 2841, Affected product was placed into Centurion Convenience Kits between July 2013 and January 2017. Batch Numbers & Exp. dates: 2016020950 4/30/18 2015052650 1/31/18 2014082550 6/30/17

General and Plastic Surgery Devices

1

No

US Distribution: NY, NC, PA, CA, OH, WA, VA, NJ, IL

POST-OPERATIVE OPHTHALMIC DRESSING TRAY || The Covidien Curity Oval Eye Pads are individually packaged and sterilized by the manufacturer; they are then placed into non-sterile Centurion Convenience Kits along with other || components.

Centurion component code 2841, Affected product was placed into Centurion Convenience Kits between July 2013 and January 2017. Batch Numbers & Exp. dates: 2016070750 10/31/18 2016051350 10/31/18 2016031850 10/31/18 2016022350 4/30/18 2015101950 4/30/18 2015081950 2/28/18 2015073050 2/28/18 2015061150 1/31/18 2015060850 1/31/18 2015041750 11/30/17 2015030550 10/31/17 2015010850 10/31/17 2014110350 7/31/17 2014071750 5/31/17

General and Plastic Surgery Devices

1

No

US Distribution: NY, NC, PA, CA, OH, WA, VA, NJ, IL

OPHTHALMIC DRESSING TRAY || The Covidien Curity Oval Eye Pads are individually packaged and sterilized by the manufacturer; they are then placed into non-sterile Centurion Convenience Kits along with other || components.

Centurion component code 2841, Affected product was placed into Centurion Convenience Kits between July 2013 and January 2017. Batch Numbers & Exp. dates: 2016102103 1/31/20 2017012303 1/31/20 2016050203 1/31/20 2016040703 1/31/20 2016031803 1/31/20 2015112303 1/31/20 2015122103 1/31/20 2015050703 2/28/20 2015092803 1/31/20 2015081703 1/31/20 2015052003 1/31/20

General and Plastic Surgery Devices

1

No

US Distribution: NY, NC, PA, CA, OH, WA, VA, NJ, IL

CUSTOM CADAVER KIT || The Covidien Curity Oval Eye Pads are individually packaged and sterilized by the manufacturer; they are then placed into non-sterile Centurion Convenience Kits along with other || components.

Model No. DYNJ05914, Lots: 17GB3101, 172B2025, 17FB9612, 17QB8614

General Hospital and Personal Use Devices

1

No

Worldwide Distribution - US Nationwide in the states of AK, AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, NC, NH, NJ, NY, OH, OK, OR, PA, TN, TX, WA and the countries of Canada, Saudi Arabia, and Netherlands.

Sterile Elastic Esmark Bandage, 3" x 9", individually packaged in a Tyvek plastic form fill seal pouch and placed into a corrugate case, 20 individually packed bandages per case.

Material Description Batch Expiration 1 CHT122O CHESTTUBETRAY 2017032350 2018-10 2017032250 2018-06 2017030650 2018-08 2017010550 2018-06 2016121450 2018-06 2016120750 2018-06 2 CHT13OS CHEST TUBE INSERTION TRAY 2017030750 2018-07 3 CHT154O CHEST TUBE INSERTION TRAY 2016112850 2018-06 4 CVI3750 PIGTAIL ACCESSORY BUNDLE 2016121550 2018-09 2016111750 2018-08 5 CV14265 VASCULAR ACCESS INSERT KIT - PEDIATRICS 2017032850 2018-07 6 CV14360 DIALYSIS KIT 2017032250 2018-07 7 PT16O LUMBAR PUNCTURE TRAY 2016120950 2018-03 8 TC7910 TRACHEOTOMY TRAY 2016051950 2018-07 2016050250 2018-07

General Hospital and Personal Use Devices

2

No

US.

SafetyGlide Needle, 22GA 1-1/2in, Catalog n. 301701, manufactured by BD, sold in || Centurion Convenience Kits. || Centurion component code BD17O1NS.

Central Venous Catheter Kit for patients >34 weeks old with the coding below were affected.   Lot Numbers: 14DB9277 and 14PB2878 Unit No: DYNDC1987A Expiration Date: 06/2015  Serial No: N/A UPC code: N/A

Cardiovascular Devices

2

No

US including PA

Central Line >34 Weeks Kit. Cardiology department. || The Central Line >34 Weeks Kit (DYNDC1987A) is intended for use on patients greater than 34 weeks of age. The central venous catheter, also called a central line, is a long, thin, flexible tube used to give medicines, fluids, nutrients, or blood products over a long period of time, usually several weeks or more. A catheter is often inserted in the arm or chest through the skin into a large vein. The catheter is threaded through this vein until it reaches a large vein near the heart.

Product Code, Lot number, Expiration date.  513604 3123326 7/1/2016 E0500-55 3123349 7/1/2016 513602 3126577 8/1/2017

General Hospital and Personal Use Devices

2

No

US Nationwide distribution.

Excelsior Disposable Syringe Heparin Lock Flush, USP syringe (5 mL Fill in 10 mL syringe). For flushing of IV catheters and IV tubing only.

Code Lot # Description exp date SUT18365 2012070350 ED SUTURE KIT Sep-14 MNS6710 2012070990 VAGINAL DELIVERY TRAY Jan-15 MNS6710 2012082090 VAGINAL DELIVERY TRAY Feb-15 MNS6710 2012092490 VAGINAL DELIVERY TRAY Apr-15 MNS6710 2012120390 VAGINAL DELIVERY TRAY Apr-15 MNS4635 2012081390 ENDOSCOPY TRAY Feb-15 OR1640 2012040990 MINOR BASIN SET Jan-15 OR1640 2012123190 MINOR BASIN SET Apr-15 OR1575 2012071690 LAPAROSCOPIC BASIN TRAY Nov-14 OR1575 2012091090 LAPAROSCOPIC BASIN TRAY Feb-15 OR1575 2013010490 LAPAROSCOPIC BASIN TRAY Apr-15

General and Plastic Surgery Devices

2

No

KS, IN, IA, KY, MT, SD

Convenience Kits from Centurion that || contain a Medtronic/Covidien Light Glove || ED SUTURE KIT || VAGINAL DELIVERY TRAY || ENDOSCOPY TRAY || MINOR BASIN SET || LAPAROSCOPIC BASIN TRAY

RIGID CANISTER 2000 cc and 3000 cc with product code OR220 and OR230. Affected Lot Numbers 9961601xxxx through 9961604xxxx

General Hospital and Personal Use Devices

2

No

US Distribution to the following states: CA , CO , FL , GA, GA , IL , MA, MA , MD , MI, MO , NC , NE , NJ , NY, NY , OH, OK , PA, TX and WA.

Rigid Suction Canister 3000 CC and 2000 CC.

Model No. MDT821203WP, all lot numbers that begin with 90317XXXXXX. "X" represents any number.

Physical Medicine Devices

1

No

USA (nationwide) Distribution to the states of : AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, NE, NH, NV, NY, OH , OK, OR, PA, RI, SC, TN, TX, VA, VT, WA, WI and WV.

Transfer/Gait Belt, Plastic, Wipeable, packaged in plastic bag, 36 plastic bags per box.

Model No. MDT821203WPL, all lot numbers that begin with 90317XXXXXX. "X" represents any number.

Physical Medicine Devices

1

No

USA (nationwide) Distribution to the states of : AL, AR, AZ, CA, CO, CT, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MT, NC, NE, NH, NV, NY, OH , OK, OR, PA, RI, SC, TN, TX, VA, VT, WA, WI and WV.

Transfer/Gait Belt, Plastic, Wipeable, packaged in plastic bag, 36 plastic bags per box.