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U.S. Department of Health and Human Services

Class 2 Device Recall Microtek Angiography Drape with Radiation Shield

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 Class 2 Device Recall Microtek Angiography Drape with Radiation Shieldsee related information
Date Initiated by FirmJuly 14, 2016
Create DateSeptember 07, 2016
Recall Status1 Terminated 3 on November 02, 2016
Recall NumberZ-2744-2016
Recall Event ID 74710
Product Classification Drape, surgical - Product Code KKX
ProductMicrotek Franz Angiography Drape with Radiation Shield, Item # RBA202, and Microtek Angiography Drape with Radiation Shield and Pouches, Item # RBA203. Sterile EO. Microtek Medical, Inc., Columbus, MS 39702.
Code Information RBA202 Lot numbers: D111574, D111654, D111724, D111864, D112024, D112094, D112224, D120164, D120454, D120544, D121144, D121314, D121674, D121944, D122204, D122554, D122854, D123324, D130354, D130454, D130914, D131704, D131994, D132464, D132974, D140834, D141204, D141774, D142244, D150404, D151334, D151464, D152304, D152364, D152454, D153084, D153204, D153494, D160544.   RBA203 Lot numbers: D122194, D122354
Recalling Firm/
Manufacturer		 Ecolab Inc
370 Wabasha St N
Saint Paul MN 55102-1323
For Additional Information ContactRoman Blahoski
651-250-4385
Manufacturer Reason
for Recall		Ecolab is recalling 2 models of Angiography Drapes with Radiation Shields because the sterile packaging may contain small holes in the film of the pouch.
FDA Determined
Cause 2		Packaging process control
ActionConsignees were sent on 7/14/2016 an Ecolab "Urgent Medical Device Recall" letter dated July 14, 2016. The letter described the problem and the product involved in the recall. Advised consignees to immediately quarantine the product and to notify their customers. For questions contact Customer Service at 1-800-824-3027.
Quantity in Commerce6750 eaches (675 cases)
DistributionUS: OH, NY, CA, MN.
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.
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