FDA Device Recall Z-0038-2007: Sunrise Medical

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0038-2007.

Recall Res Number

Z-0038-2007

Recalling Firm / Manufacturer

Sunrise Medical

FEI Number

2515872

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2006-08-24

Date Posted

2006-10-17

Date Terminated

2009-08-27

Product Code

CAW

Event Number

36174

Product Quantity

252 units

Product Description DeVilbiss iFill Personal Oxygen Station model number 535D.

Reason for Recall Potential for oxygen cylinders to not fill completely

Action Details The recalling firm began to notify customers via telephone beginning on 8/24/06. An 'Urgent Medical Device Recall' letter was sent on 8/28/06. Customers were advised what model and serial numbers were affected and how to contact the firm and/or dealer to have the unit replaced. A customer service help line has been established (1-800-333-4000) to provide additional information for returning units.

Distribution Pattern The product was distriubted to 252 end users nationwide through 36 dealers.

Code Information / Serial Numbers serial numbers AD01145 through AD01462

Related Establishments / Registrations

VINCENT MEDICAL MANUFACTURING. CO., LTD. Registration: 1000604079 View Registration
NIDEK MEDICAL PRODUCTS, INC. Registration: 1039215 View Registration
ISOMEDIX OPERATIONS INC. Registration: 1220477 View Registration
AIRSEP CORP. Registration: 1319044 View Registration
Ohio Medical LLC Registration: 1419185 View Registration
Allied Medical LLC Registration: 1924066 View Registration
WESTMED, INC. Registration: 2028807 View Registration
PACIFIC CONSOLIDATED INDUSTRIES, LLC Registration: 2032532 View Registration
FISHER & PAYKEL HEALTHCARE, INC. Registration: 2085602 View Registration
LIFE CORPORATION Registration: 2183615 View Registration
DeVilbiss Healthcare LLC. Registration: 2515872 View Registration
RESPIRONICS INC. Registration: 2518422 View Registration
PRECISION MEDICAL, INC. Registration: 2523148 View Registration
Philips Electronics Ltd Registration: 3000126629 View Registration
Respironics Deutschland GmbH & Co.KG Registration: 3001400310 View Registration
MOLECULAR PRODUCTS LTD Registration: 3002807637 View Registration
GCE, s.r.o. Registration: 3003207908 View Registration
ON SITE GAS SYSTEMS, INC. Registration: 3003637574 View Registration
EMG TECHNOLOGY CO., LTD. Registration: 3003803075 View Registration
KMI IMI GROUP / DBA: INNOVATIVE MED, INC. Registration: 3004112621 View Registration
INOGEN, INC. Registration: 3004672275 View Registration
AVOX SYSTEMS Registration: 3004964590 View Registration
CAIRE INC. Registration: 3004972304 View Registration
BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. Registration: 3005569927 View Registration
Westmed Javid de Mexico, S.A. de C.V. Registration: 3005587132 View Registration
THORNHILL RESEARCH INC. Registration: 3005803793 View Registration
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Creative Foam Corporation dba MT. OLIVE MFG Registration: 3006240053 View Registration
DANYANG HUAYI MEDICAL SUPPLY & EQUIPMENT CO, LTD Registration: 3006534178 View Registration
LONGFIAN SCITECH CO., LTD. Registration: 3006991053 View Registration
RESPIRONICS, INC. Registration: 3007220521 View Registration
SHENYANG CANTA MEDICAL TECH. CO., LTD Registration: 3007307467 View Registration
Flextronics Manufacturing Juarez S. DE R.L. DE C.V. Registration: 3007344957 View Registration
RESMED CORP Registration: 3007573469 View Registration
FOSHAN CARE MEDICAL TECHNOLOGY CO., LTD. Registration: 3008220943 View Registration
CHOICEMMED AMERICA CORPORATION Registration: 3008507279 View Registration
Oxus America, Inc. Registration: 3008841036 View Registration
O2 CONCEPTS, LLC Registration: 3008910673 View Registration
3B Medical Inc Registration: 3009096682 View Registration
CAIRE INC. Registration: 3009128734 View Registration
CAIRE Medical Technology (Chengdu) Co., Ltd. Registration: 3009550619 View Registration
Drive DeVilbiss Healthcare Registration: 3009683397 View Registration
SHENZHEN HOMED MEDICAL DEVICE CO LTD Registration: 3010287621 View Registration
TRIBALCO Registration: 3010317211 View Registration
SYSMED (CHINA) CO., LTD Registration: 3010440667 View Registration
Plexus Electronica S. de R.L. de C.V.. Registration: 3011120183 View Registration
VIVE Health LLC Registration: 3011191255 View Registration
ResMed Corp Registration: 3011205710 View Registration
ZHENGZHOU OLIVE ELECTRONIC TECHNOLOGY CO., LTD. Registration: 3011249646 View Registration
SEASIDE MARINE INTERNATIONAL DRUG CO., INC. Registration: 3011767915 View Registration
GAS CONTROL EQUIPMENT LTD Registration: 3011895992 View Registration
COMPASS HEALTH BRANDS (CORPORATE OFFICE) Registration: 3012316249 View Registration
SHENZHEN HOMED MEDICAL DEVICE CO LTD Registration: 3013000203 View Registration
VENTEC LIFE SYSTEMS, INC. Registration: 3013095415 View Registration
FOXCONN EUROPEAN MANUFACTURING SERVICES S.R.O. Registration: 3014661487 View Registration
QINGDAO KINGON MEDICAL SCIENCE AND TECHNOLOGY CO.,LTD Registration: 3014777423 View Registration
JIANGSU JUMAO X-CARE MEDICAL EQUIPMENT CO., LTD Registration: 3014810929 View Registration
Tianjin Choice Medical Device Co., Ltd. Registration: 3015142815 View Registration
Drive DeVilbiss Healthcare Registration: 3015772781 View Registration
GUANGZHOU LIFE LIGHT ELECTRONIC TECHNOLOGY CO., LTD. Registration: 3016809216 View Registration
JIANGSU KONSUNG BIO-MEDICAL SCIENCE AND TECHNOLOGY CO LTD Registration: 3016859940 View Registration
VENTEC LIFE SYSTEMS, INC. Registration: 3017520736 View Registration
KBBIO CO., LTD. Registration: 3017608802 View Registration
ResMed Asia Pte. Ltd. Registration: 3017684630 View Registration
JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD. Registration: 3017825461 View Registration
CEVA LOGISTICS NETHERLANDS BV (Venray) Registration: 3018783526 View Registration
Inogen, Inc Registration: 3019385742 View Registration
LINAMAR INNOVATION HUB Registration: 3020476987 View Registration
FOSHAN MIC MEDICAL TECHNOLOGY CO., LTD Registration: 3023245116 View Registration
CEVA LOGISTICS LIMITED Registration: 3023272766 View Registration
Novair USA Corp. Registration: 3025889185 View Registration
Kimball Electronics - Mexico SA de CV Registration: 3027241818 View Registration
Philips Global Business Services LLP Registration: 3029227324 View Registration
BEIJING CHOICEMMED TECHNOLOGY CO., LTD. Registration: 3032013079 View Registration
Philips India Limited - Sleep & Respiratory Care Business Unit Registration: 3033526676 View Registration
SHENZHEN HARVEYMED TECHNOLOGY CO., LTD. Registration: 3033814505 View Registration
FOSHAN KYCARE MEDICAL EQUIPMENT CO. LTD Registration: 3033859527 View Registration
NANJING YINUOJI MEDICAL TECHNOLOGY CO., LTD. Registration: 3037045878 View Registration
3B MEDICAL INC Registration: 3042507287 View Registration
Drive DeVilbiss Healthcare Registration: 3043460907 View Registration
JAKAMED INSTRUMENTS CO.,LTD. Registration: 3043648593 View Registration
FISHER & PAYKEL HEALTHCARE, LTD. Registration: 9611451 View Registration
WESTMED de Mexico, S.A de C.V. Registration: 9710644 View Registration

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This page represents an index of public-record FDA device recalls. It does not imply current safety or compliance status of the product. AvaSpecs is a private aggregator and is not affiliated with the FDA or any government agency. This page does not constitute medical, safety, legal, regulatory, or compliance advice. Refer to official government sources for primary safety alerts.

Medical Device Recall: Z-0038-2007

Recall Parameters & Description

Related Establishments / Registrations

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