Recall Z-2744-2016
Ecolab Inc · initiated July 14, 2016
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: 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
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: 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.
Details
- Recall number
- Z-2744-2016
- Initiated
- July 14, 2016
- Terminated
- November 2, 2016
- Product code
- KKX – Drape, Surgical, Antimicrobial
- Quantity
- 6750 eaches (675 cases)
- Distribution
- US: OH, NY, CA, MN.
- Recalling firm
- Ecolab Inc, Saint Paul, MN