FDA Medical Device Recalls (openFDA)
Ecolab Inc: 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.
- Recall number
- Z-2744-2016
- Recalling firm
- Ecolab Inc
- 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.
- Status
- Terminated
- Initiated
- 2016-07-14
- Posted
- not on file
- Terminated
- 2016-11-02
- Reason
- 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.
- Root cause
- Packaging process control
- Action
- 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.
- Quantity
- 6750 eaches (675 cases)
- Distribution
- US: OH, NY, CA, MN.
- Lot, serial or model codes
- 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
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KKX
- Firm FEI
- 1000289767
- Firm city
- Saint Paul
- Firm state
- MN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28