Device Recall Nipro

Lot #'s 13E02, 13E03, 13E06, 13E07, 13E08,13E09, 13E10, 13G03, 13G11, 13G15, 14G24, 13G30, and 13H06.

Gastroenterology-Urology Devices

2

No

US Distribution to states of: TN and NJ.

NIPRO SET / SLIMLINE BLOOD TUBING SET for Hemodialysis with Transducer Protectors and Priming Set || A disposable bloodline intended to provide extracorporeal access to the patient's blood during Hemodialysis. Compatible for use with Fresenius 2008H, 2008K/K2 and 2008T dialysis machines.

Model No. BL+A223D/V809D, Vendor Batch No. 17I06-9, 17I16-9, 17I18-9, 17J17-9, 17J19-9 , 17J20-9 , 17J21-9, 17I19-9, 17K07-9 , 17I01-9, 17J12-9, 17J16-9, 17I21-9, 17I25-9, 17I26-9, 17J09-9, 17J11-9, 17K15-9, 17K16-9.

Gastroenterology-Urology Devices

2

No

US Distribution to the states of : GA, NY, TN, TX.

Nipro Blood Tubing set with Priming Set and Transducer Protectors. Each device is packaged in a film pouch with 24 lines per case. || The Nipro¿ Set - Blood Tubing Set with Transducer Protector and Priming Set are disposable bloodlines intended to provide extracorporeal access to the patient s blood during hemodialysis. The compatibility of available configurations is the responsibility of the physician in charge.

All lot numbers in current distribution are under recall.

Gastroenterology-Urology Devices

2

No

Nationwide and Canada

The following brand name labeled products are under recall (all || catalog numbers and all lot numbers under recall): || NIPRO SafeTouch Safety Fistula Needle, Baxter Safety AV Fistula || Set and EXEL Secure Touch Safety AV Fistula Needle Set.

A08022,  A08013,  A08017,  C08022,  C08013,  C08017,  B08013,  B08017.

General Hospital and Personal Use Devices

2

No

US (including Puerto Rico) Foreign Distribution: Canada, Barbados, Honduras, Jamaica, Panama, Trinidad and Tobago, and Costa Rica.

NIPRO, GLUCOPRO INSULIN SYRINGES, SINGLE USE INSULIN SYRINGE with needle, 1CC 30g 5/16", U-100 INSULIN, LATEX FREE. Distributed by: NIPRO MEDICAL CORPORATION 3150 N.W. 107th Ave., Miami, Florida 33172. || Packaged 10 syringes in a pouch, 10 pouches in a box (100 pieces), 5 boxes in a case (500 pieces). || JD+01U3008-5C 1cc 30G x 5/16"; || JD+01U3013-5C 1cc 30G x 1/2"; || JD+01U3108-5C 1cc 31G x 5/16"; || JD+03U3008-5C .3CC 30 g X 5/16"; || JD+03U3013-5C .3CC 30 g X 1/2"; || JD+03U3108-5C .3cc 31G x 516"; || JD+05U3008-5C .5cc 30G x 5/16"; || JD+05U3013-5C .5cc 30G x 1/2"; || JD+05U3108-5C .5cc 31G x 5/16".