Device 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.
Z-2744-2016
Product summary
- Firm
- Ecolab Inc
- Event
- Event 74710
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6750 eaches (675 cases)
- Official record key
device-enforcement:Z-2744-2016
Official wording
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.
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
Distribution pattern: US: OH, NY, CA, MN.
Derived failure modes
-
Unknown
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.