FDA Device Recall Z-0001-06: VIASYS Med Systems

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0001-06.

Recall Res Number

Z-0001-06

Recalling Firm / Manufacturer

VIASYS Med Systems

FEI Number

3011270181

Recall Status

Terminated

Recall Classification

N/A

Date Initiated

2005-09-13

Date Posted

2005-10-04

Date Terminated

2005-12-30

Product Code

FXY

Event Number

33407

Product Quantity

481 cases

Product Description Stackhouse FreedomAire Lens/Hood; a sterile disposable protective head garment for use with the FreedomAire Surgical Helmet System, providing a clear plastic bubble lens and protective head hood to connect to the surgical helmet; individually packaged hoods, 12 per case; Manufactured for Viasys MedSystems, Wheeling, IL 60090

Reason for Recall The packaging may be compromised such that sterility of the hoods cannot be guaranteed.

Action Details VIASYS telephoned the direct accounts and sent out follow-up faxes on 9/13/05. The accounts were informed of the potential for compromised packages seals and questionable sterility, and were instructed to check their inventory for the affected catalog numbers and lots numbers. The accounts were instructed to hold any affected product and contact VIASYS at 1-800-323-6305 to arrange for the return goods authorization. The dealers were requested to sub-recall the affected product from their customers.

Distribution Pattern Nationwide and internationally to Japan, Chile and Switzerland

Code Information / Serial Numbers Part #10450, Catalog # SA-500/US, lot number 16963

Related Establishments / Registrations

DEROYAL INDUSTRIES, INC. Registration: 1043214 View Registration
DeRoyal Industries, Inc. Registration: 1054241 View Registration
DEROYAL INDUSTRIES, INC. Registration: 1055236 View Registration
ZIMMER SURGICAL, INC. Registration: 1526350 View Registration
Sterigenics U.S., LLC Registration: 1721686 View Registration
Isomedix Operations, Inc Registration: 2032098 View Registration
STERIS SPA Registration: 3002806603 View Registration
Sterigenics Germany GmbH Registration: 3002807090 View Registration
AccuMed Corp. Registration: 3007309299 View Registration
Sterigenics S. de R.L. de C.V. Registration: 3008328679 View Registration
STRYKER EMEA Supply Chain Services Registration: 3008837339 View Registration
Sterigenics Costa Rica S.R.L. Registration: 3010432890 View Registration
Avanos Medical, Inc. Registration: 3011270181 View Registration
SANICURE BV Registration: 3012494290 View Registration
Stryker US Supply Chain Operations Registration: 3012497308 View Registration
CBR ENTERPRISE LIMITED Registration: 3013557562 View Registration
PROEX CORP, S.R.L. Registration: 3014213264 View Registration
SANMED MEDIKAL OTOMOTIV TEKSTIL TICARET LIMITED SIRKETI Registration: 3014479313 View Registration
Stryker Instruments Registration: 3015967359 View Registration
Schneider ASR B.V. Registration: 3016678045 View Registration
THI TOTAL HEALTHCARE INNOVATION GMBH Registration: 3017300722 View Registration
Stryker Tijuana Operations Registration: 3020163307 View Registration
AD SUPPLY GROUP LIMITED Registration: 3030733800 View Registration
THI Medikal Sanayi Ticaret A.S Registration: 3031572397 View Registration
MAYA MEDICAL TOP TRADE LTD. Registration: 3036773433 View Registration

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Medical Device Recall: Z-0001-06

Recall Parameters & Description

Related Establishments / Registrations

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