Recall Z-2793-2015 ยท LHC Warmer, Irrigation Solution
Ecolab Inc
Microtek Medical, Inc. ORS Fluid Warming and Slush Drapes, Model #'s ORS-100, ORS-110, ORS-130, ORS-300, ORS-301, ORS-320, ORS-321, ORS-325, ORS-330, ORS-331 and ORS-2200. The ORS Fluid Warming and Slush Drapes are individually wrapped and placed in poly-Tyvek pouches with a label insert, then packaged as 24 per case in a labeled corrugated shipper box. Intended for use during various surgerie
| Date | Sep 18, 2015 (initiated Aug 18, 2015) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Package design/selection |
| Action | 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. |
| Quantity | 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. |
| FDA record | Open on fda.gov |