Microtek 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.
This recall has been terminated (originally issued July 14, 2016).
- Company
- Ecolab Inc
- Recall Initiated
- July 14, 2016
- Terminated
- November 2, 2016
- Recall Number
- Z-2744-2016
- Quantity
- 6750 eaches (675 cases)
- Firm Location
- Saint Paul, MN
- Official Source
- View on FDA website ↗
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.
Distribution
US: OH, NY, CA, MN.
Lot / Code Info
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
Root Cause
Packaging process control
Action Taken
Consignees 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.