ClearanceBrief
Panels › General Hospital › Product code KPE · Class 2

Container, I.V.

Regulation 880.5025

3510(k)s in 12 months (117 all time)
0recalls in 12 months (62 all time)
57recalls that name a 510(k)
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Top companies in KPE

Company510(k)sRecalls
Metrix Co.225
Baxter Healthcare Corp810
Baxa Corporation015
Abbott Laboratories60
Baxa Corp., Sub. of Cook Group, Inc.50
Microtek Medical Inc.05
Gil-Med Industries C/O Kegan & Kegan, Ltd.40
Medi-Plast Intl., Inc.40
Williams Medical Co.40
Advance Medical Designs, Inc.30
DateFirm and productCodeLinked 510(k)
Aug 2, 2010Baxa Corporation
Exacta-Mix EVA Container, Sterile R, 3000 mL, Order No. REF: 141, Baxa Corporation.
Terminated		 KPEK900585
Aug 2, 2010Baxa Corporation
Exacta-Mix EVA Container, Sterile R, 2000 mL, Order No. REF: 140, Baxa Corporation.
Terminated		 KPEK900585
Aug 2, 2010Baxa Corporation
Exacta-Mix EVA Container, Sterile R, 1000 mL, Order No. REF: 139, Baxa Corporation.
Terminated		 KPEK900585
Aug 2, 2010Baxa Corporation
Exacta-Mix EVA Container, Sterile R, 500 mL, Order No. REF: 138, Baxa Corporation.
Terminated		 KPEK900585
Aug 2, 2010Baxa Corporation
Exacta-Mix EVA Container, Sterile R, 250 mL, Order No. REF: 137, Baxa Corporation.
Terminated		 KPEK900585
Apr 29, 2010Baxter Healthcare Corp.
Baxter Evacuated Container, 500 mL, Sterile, non pyrogenic, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Made in USA, product code 1A8503.
Terminated		 KPENone listed
Apr 29, 2010Baxter Healthcare Corp.
Baxter Evacuated Container, 250 mL, Sterile, non pyrogenic, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Made in USA, product code 1A8502.
Terminated		 KPENone listed
Mar 9, 2010Baxa Corporation
Exacta Mix TPN (total parenteral nutrition) Bag, Model 740, 2000mL, Baxa Corporation
Terminated		 KPEK900585
Mar 9, 2010Baxa Corporation
Exacta Mix TPN (total parenteral nutrition) Bag, Model 739, 1000mL, Baxa Corporation
Terminated		 KPEK900585
Mar 9, 2010Baxa Corporation
Exacta Mix TPN (total parenteral nutrition) Bag, Model 738, 500mL, Baxa Corporation.
Terminated		 KPEK900585
May 25, 2006Instituto Grifols, S.A.
Gri-bag: A single use, non pyrogenic flexible empty container with an incorporated 0.2 micron filter. It is supplied sterile in sealed peel-pack pouches. It is used to remove particulates in the Gri-
Terminated		 KPEK033916
Mar 3, 2006B. Braun Medical Inc
B. Braun Hyperformer EVA Mixing Container with Hyperformer Compatible Connector, 4000ml size, Catalog Number SH4000, Batch Numbers 05A14474, 05A18561, and 05A19926
Terminated		 KPENone listed

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