Centurion Medical Products Corporation

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.

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: 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.