Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-32

FDA device recall Z-2793-2015 · posted 2015-09-18 · Terminated

Recall details

Recalling firm

Ecolab Inc

Reason for recall

The sterile packaging may contain small (less than 250 microns wide) channels in the seal of the pouch. If channels are present, the package integrity is compromised and there is a remote chance that a non-sterile drape may be used during a surgical procedure.

Action taken

Consignees were sent on 8/18/2015 an Ecolab "Urgent Medical Device Recall" letter dated August 18, 2015. The letter was addressed to Recall Coordinator or Risk Manager. The letter described the problem and the product involved in the recall. Advised consignees to quarantine all affected lots, and notify their customers of the recall which is to be carried out to users level. Requested consignees to complete and return the enclosed Recall Response Form. For questions they can contact Customer Service at 1-800-824-3027 or e-mail customerservice@microtekmed.com.

Root cause

Package design/selection

Status

Terminated

Product code

LHC

Quantity affected

5,172,816 units

Distribution

Worldwide Distribution -- US, including DC and PR; and, the countries of SAUDI ARABIA, LEBANON, GERMANY, HONG KONG, SINGAPORE, CANADA, and JAPAN.

Date initiated

2015-08-18

Date posted

2015-09-18

Date terminated

2017-08-09

Location

Saint Paul, MN

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