Z-2744-2016Class II

Microtek Franz Angiography Drape with Radiation Shield, Item # RBA202, and Microtek Angiography Drape with...

Name: Z-2744-2016 Microtek Franz Angiography Drape with Radiation Shield, Item # RBA202, and Microtek Angiography Drape with...
Creator: Ecolab Inc
Published: 2016-07-14
License: https://open.fda.gov/license/

Microtek Medical LLC / initiated 2016-07-14 / Terminated / root cause: packaging

FDA source

Ecolab Inc began a recall of Microtek Franz Angiography Drape with Radiation Shield, Item # RBA202, and Microtek Angiography Drape with Radiation Shield and Pouches, Item # RBA203. Sterile... on 2016-07-14. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2744-2016
Classification: Class II
Status: Terminated
Initiated: 2016-07-14
Posted: 2016-09-07
Terminated: 2016-11-02
Recalling firm: Microtek Medical LLC
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.
Product code: KKX Drape, Surgical, Antimicrobial
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.
Root cause tag: packaging
FDA 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 in commerce: 6750 eaches (675 cases)
Distribution: US: OH, NY, CA, MN.
Product codes and 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2744-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2744-2016	Class II	Terminated	Voluntary: Firm initiated	2016-09-14	2016-09-07

Product code KKX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)