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U.S. Department of Health and Human Services

Class 2 Device Recall GEHealthcare, Drapes and Sterile Covers

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 Class 2 Device Recall GEHealthcare, Drapes and Sterile Covers see related information
Date Posted August 14, 2009
Recall Status1 Terminated on May 15, 2012
Recall Number Z-1730-2009
Recall Event ID 51722
510(K)Number K021049  K993687  K970185  K820692  K782155 
Product Classification Protective Cover, Barrier - Product Code MMP
Product GE Healthcare, Drapes and Sterile Covers

PART NUMBER DESCRIPTION

00-900352-01 DRAIN BAG W/HOSE (2000/2500) 2.0 PE MATERIAL
00-900352-01-OEC STRL, BAG, DRAIN WITH PLASTIC CLIPS AND HOSE 2000,2500

00-900352-02 STRL, BAG, DRAIN WITH METAL TABS

00-900493-03 COVER DISPOSABLE X-RAY TUBE

00-900605-01 UROFAST DRAIN BAG (UROFAST ONLY)

00-900605-01-OEC STRL, BAG, DRAIN, WITH HOSE, UROFAST

00-900885-01 URO2600 DRAIN BAG 2.0 PE MATERIAL

00-900885-01-OEC STRL, BAG, DRAIN, URO2600

00-900943-01 STRL, COVER, CARM, HALF BAG, 36X80, 90,94,76
00-900974-01 STRL, DRAPING, MINI-CARM, KYBRD, BLK FTSW, 6600

00-901072-01 URO 2600 DISPOSABLES PACK 2.0 PE MATERIAL

00-901072-01-OEC STRL, PACK, DISPOSABLES, UROVIEW 2600

00-901169-01 12 TUBE DRAPE (36X36) 2.0 PE MATERIAL

00-901169-01-OEC STRL, COVER, DISPOSABLE, 12 INCH TUBE 9600
00-901268-01 DRAPE,STERIQUIK, STANDARD&SUPER-
C,9600/7700

00-901390-01 STRL, DRAPING, KEYBOARD, FOOTSWITCH, 20PACK, 6600

00-901391-01 STRL, DRAPE, C-ARM ONLY, 6600

00-901392-01 STRL, COVER, KEYBOARD, 66,68

00-901501-01 9600/9800/SUPER C DISPOSABLES PACK 2.0 PE MATERIAL

00-901501-01-OEC STRL, PACK, DISPOSABLES, MODEL 9800, 20 PACK
00-901581-01-OEC STRL, COVER, DISPOSABLE, IR REMOTE, 9600, 9800
00901588-01 12 C ARM DISPOSABLES PACK 2.0 PE MATERIAL
00-901588-01-OEC STRL, PACK, DISPOSABLES, 12 INCH, 20 PACK SCD 9600

00-901761-01 STRL, DISPOSABLES PACK, UROVIEW 2800

00-901831-02 STRL, COVER, FLUOROTRAK MONITOR,
DISPOSABLE BOX 10 PER PKG

00-901832-01 STRL, APIX, COVER, DISPOSABLE CONTROLPANEL COVERS, REPLACEMENT PART CASE OF 25

00-901917-01 STRL, DRAPE, C-ARM, 6800

00-901918-01 MINIVIEW 6800 C-ARM CONSUMABLES PACK GRAY FOOTSWITCH

00-901918-01-OEC STRL, DRAPE, 20 PACK, 6800

00-902752-01 STRL, RUI COVERS 25 COVERS

00-902753-01 STRL, PACK, DISPOSABLE, 9800MD, 9 INCH 20 PACKS

00-902754-01 STRL, PACK, DISPOSABLE, 9800MD, 12 INCH 20 PACKS

00-902776-01 STRL, DRAPE, VASCULAR

00-902864-01 STRL, DRAPE, HALF, C ARM, 9800 9600

00-902934-01 STRL, DRAPE, WORKSTATION, 20 PER BOX, 9900
1003135 STRL, BAG, FLAT PANEL

E7009AE STRL, DRAPE, AFM/CFM PEDESTAL, 25 PER BOX

E7009AF STRL, DRAPE, AFM/CFM JOYSTICK, 50 PER BOX

E7009AG STRL, DRAPE, LARGE DOME BAG, 20 PER BOX

E7009AH STRL, DRAPE, MEDIUM DOME BAG, 20 PER BOX

E7009AJ STRL, DRAPE, SMALL DOME BAG, 20 PER BOX

Sterile EO, Distributed by GE Medical Systems, Milwaukee, WI 53201, Manufactured by Contour Fabricators, Inc. Fenton, MI 48430.

The disposable sterile product provide a sterile barrier between the imaging device and sterile surgical field.
Code Information all codes
Recalling Firm/
Manufacturer
GE Medical Systems, LLC
3000 N Grandview Blvd
Waukesha WI 53188-1615
For Additional Information Contact
262-544-3894
Manufacturer Reason
for Recall
GE Healthcare has found that the sterile products manufactured by Contour Fabricators, Inc. (CFI) for GE healthcare (GEHC) may have sterile seals that could be compromised during the shelf life of the products. This issue could result in the product not maintaining its sterile state.
FDA Determined
Cause 2
Release of Material/Component prior to receiving test results
Action Consignees were sent 8/29/08 a GE Healthcare "Urgent Recall Notice" dated August 15, 2008. The letter was addressed to Director / Manager of Radiology and Director of Surgery. The letter described the problem and provided a list of products, solutions and requested the return of the attached fax forms. In the event of any questions or concerns, a service team should be contacted at 800-874-7378 option #8.
Quantity in Commerce 137,689 (123,373 US; 14,316 OUS)
Distribution Worldwide Distribution -- USA, Canada, Australia, Bahamas, China, Hong Kong, Italy, Japan, Korea, Mexico, Malaysia, Singapore, and El Salvador.
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = MMP and Original Applicant = CONTOUR FABRICATORS, INC.
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