FDA Device Recall Z-0032-2007: Gambro Renal Products, Inc.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0032-2007.

Recall Res Number

Z-0032-2007

Recalling Firm / Manufacturer

Gambro Renal Products, Inc.

FEI Number

1713683

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2006-05-16

Date Posted

2006-10-12

Date Terminated

2012-01-03

Product Code

KDI

Event Number

36199

Product Quantity

153 units (US)

Product Description Gambro Prismaflex Hemodialysis Machine, Catalogue Number 6023014700, Gambro Dasco S.p.A, Italy.

Reason for Recall A potential risk of infusing air or infusion fluid to the patient during dialysis. Also, a possibility of an incorrect scale reading of the amount of patient fluid removal.

Action Details Consignees were notified by letter on 05/16/2006.

Distribution Pattern Nationwide.

Code Information / Serial Numbers Serial numbers: PA0101 to PA0681.

Related Establishments / Registrations

STERLAB Registration: 1000286794 View Registration
BELLCO Srl Registration: 1000312731 View Registration
ISOMEDIX OPERATIONS INC. Registration: 1047843 View Registration
NIPRO MEDICAL CORPORATION Registration: 1056186 View Registration
Fresenius Medical Care Renal Therapies Group, LLC Registration: 1225714 View Registration
Sterigenics US LLC Registration: 1649518 View Registration
Fresenius USA Manufacturing, Inc. Registration: 1713747 View Registration
Sterigenics U.S., LLC Registration: 1721676 View Registration
Isomedix Operations, Inc Registration: 2032098 View Registration
Isomedix Operations, Inc. Registration: 2183744 View Registration
NIPRO CORPORATION Registration: 3000247873 View Registration
PAR MEDIZINTECHNIK GMBH & Co. KG Registration: 3001744144 View Registration
KOGA ISOTOPE LTD. Registration: 3002807408 View Registration
B. Braun Avitum AG Registration: 3002879653 View Registration
NEPHROS, INC. Registration: 3003337893 View Registration
NXSTAGE MEDICAL, INC. Registration: 3003464075 View Registration
Gambro UF Solutions LLC Registration: 3003504604 View Registration
Flextronics Manufacturing (Singapore) Pte Ltd Registration: 3003589956 View Registration
KLUGE DESIGN INC. Registration: 3003661577 View Registration
Sterigenics US LLC Registration: 3004111573 View Registration
B. Braun Avitum AG Registration: 3004176176 View Registration
B. Braun Avitum Saxonia GmbH Registration: 3004201412 View Registration
ANDERSEN CALEDONIA LTD Registration: 3004530184 View Registration
Fresenius USA Manufacturing, Inc. Registration: 3005162618 View Registration
Haemotec, a division of Fresenius Medical Care Canada Inc. Registration: 3005578748 View Registration
SARMED SRL Registration: 3005695808 View Registration
Sterigenics Belgium Petit Rechain S.A. Registration: 3005941719 View Registration
STERLAB Registration: 3006174295 View Registration
Bieffe Medital Manufacturing Oued Ellil Tunisia Registration: 3006755813 View Registration
Nuwellis, Inc. Registration: 3007137787 View Registration
Synergy Health Radeberg GMBH Registration: 3008102042 View Registration
M. E. NIKKISO CO., LTD. Registration: 3008229990 View Registration
Terumo Medical Canada, Inc. Registration: 3008307705 View Registration
VALMED SRL Registration: 3009128476 View Registration
AvailMed S.A.De C.V. Registration: 3010291427 View Registration
Outset Medical, Inc. Registration: 3010355846 View Registration
PT. Nipro Indonesia Jaya Registration: 3010377171 View Registration
STERISERVICES Registration: 3010383847 View Registration
Steril Verona srl Registration: 3011554160 View Registration
Synergy Health AST, LLC Registration: 3012102437 View Registration
LIDER Registration: 3012149633 View Registration
SANICURE BV Registration: 3012494290 View Registration
ORTA MEDICAL LTD Registration: 3013188547 View Registration
QUANTA DIALYSIS TECHNOLOGIES LTD Registration: 3013536188 View Registration
CBR ENTERPRISE LIMITED Registration: 3013557562 View Registration
B. BRAUN MEDICAL INC. Registration: 3013764800 View Registration
INFOMED SA Registration: 3014272786 View Registration
MKA MEDIKAL IC VE DIS TICARET SANAYI LIMITED SIRKETI Registration: 3014279513 View Registration
B.Braun Avitum Saxonia GmbH Registration: 3014300273 View Registration
SANMED MEDIKAL OTOMOTIV TEKSTIL TICARET LIMITED SIRKETI Registration: 3014479313 View Registration
WORLDWIDE SUPPLIES LIMITED Registration: 3014579161 View Registration
Steril Verona srl Registration: 3015136750 View Registration
ERIKA DE REYNOSA, S.A. DE C.V. Registration: 3015335038 View Registration
DIALITY, INC. Registration: 3015349756 View Registration
I-DIALCO INC. Registration: 3015472042 View Registration
TST GmbH Registration: 3016096143 View Registration
SHIBUYA CORPORATION Registration: 3016250252 View Registration
Schneider ASR B.V. Registration: 3016678045 View Registration
Baja Fur S.A. de C.V. Registration: 3017552925 View Registration
Quanta Dialysis Technologies Ltd Registration: 3020689844 View Registration
IVUS ILAC SANAYI VE TICARET AS Registration: 3021632375 View Registration
RELIABLE HEALTHCARE LOGISTICS, LLC Registration: 3027592507 View Registration
Erika de Reynosa, S.A. de C.V. Registration: 3031565407 View Registration
VANTIVE HEALTHCARE TECHNOLOGIES PRIVATE LIMITED Registration: 3032828299 View Registration
Vantive Health GmbH Registration: 3033903155 View Registration
Pabst Transport GmbH & Co. KG Registration: 3035708507 View Registration
Baja Fur S.A. de C.V. Registration: 3038138522 View Registration
Vantive US Healthcare LLC Registration: 3038195011 View Registration
NIKKISO CO., LTD. KANAZAWA PLANT Registration: 3040314808 View Registration
GXO Logistics H France Registration: 3043014136 View Registration
ZAPALIGN LLC Registration: 3043226252 View Registration
GAMBRO INDUSTRIES Registration: 8010182 View Registration
BAXTER S.A. DE C.V. Registration: 8030639 View Registration
ERIKA DE REYNOSA, S.A. DE C.V. Registration: 8030665 View Registration
NIKKISO CO., LTD. - SHIZUOKA PLANT Registration: 8031561 View Registration
Nipro (Thailand) Corporation Limited Registration: 8041145 View Registration
GAMBRO DASCO S.P.A., BLOOD LINE DIVISION Registration: 9610270 View Registration
B. BRAUN MELSUNGEN AG Registration: 9610825 View Registration
NIPRO CORPORATION ODATE FACTORY Registration: 9610987 View Registration
GAMBRO DIALYSATOREN GMBH Registration: 9611369 View Registration
FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH Registration: 9611823 View Registration
FRESENIUS MEDICAL CARE DEUTSCHLAND GMBH Registration: 9611824 View Registration
Baxter Healthcare, S.A. Registration: 9612052 View Registration
Medica S.p.A. Registration: 9615942 View Registration
MEDIMEXICO, S. DE R.L. DE C.V. Registration: 9616074 View Registration
GAMBRO DASCO S.P.A., MONITORS DIVISION Registration: 9616240 View Registration
Sterigenics Radiation Technologies Canada, Inc Registration: 9680579 View Registration
SORIN GROUP ITALIA S.R.L Registration: 9680841 View Registration
Gammatom S.r.l. Registration: 9681465 View Registration

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Medical Device Recall: Z-0032-2007

Recall Parameters & Description

Related Establishments / Registrations

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