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Recall Observatory FDA recall evidence

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

July 14, 2016

Class II

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

    reason.no_named_rule · v1.0.0

    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.