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U.S. Department of Health and Human Services

Class 2 Device Recall GE sterile drape

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 Class 2 Device Recall GE sterile drapesee related information
Date Initiated by FirmAugust 15, 2008
Date PostedSeptember 01, 2009
Recall Status1 Terminated 3 on May 15, 2012
Recall NumberZ-1709-2009
Recall Event ID 52561
510(K)NumberK021049 K782155 K820692 K970185 K993687 
Product Classification Cover, barrier, protective - Product Code MMP
ProductDisposable Pack, Headset Part Number 888946-01(kit includes Part Number 888944-01, Sterile, Drape, Headset, Lower and Part Number 888945-01, Sterile, Drape, Headset, Upper).
Code Information all lots
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 seals that could be compromised during the shelf life of the products. This issue could result in the product not maintaining its sterile state. Eleven complaints and 3 MDR's have been filed. No illness or injuries reported.
FDA Determined
Cause 2		Packaging process control
ActionGE Healthcare issued an Urgent Recall Notice dated August 15, 2008. The letter described the problem, provided a list of products, instructed customers to stop using the products and to return or dispose. To receive credit, customers must complete the attached product return form and include it in the package with returned items. All customers were asked to complete and fax back the attached response form.
Quantity in Commerce50 each
DistributionNationwide Distribution -- AZ, CA, FL, MD, NY, OR, PA, SC and TX.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = MMP
510(K)s with Product Code = MMP
510(K)s with Product Code = MMP
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