Z-2744-2016 Class II Terminated
FDA device recall Z-2744-2016 was initiated by Ecolab Inc on July 14, 2016 and is designated Class II. 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. The recall status is terminated (terminated November 2, 2016). Affected quantity: 6750 eaches (675 cases).
Recall Details
- Product Type
- Devices
- Report Date
- September 14, 2016
- Initiation Date
- July 14, 2016
- Termination Date
- November 2, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6750 eaches (675 cases)
Product Description
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.
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 Pattern
US: OH, NY, CA, MN.
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