FDA Device recall Z-2793-2015
Microtek Medical, Inc
- FDA Device
- Class II
- terminated
- Published 2015-09-30
On 2015-09-30 the FDA classified a Class II recall of Microtek Medical, Inc by Ecolab, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2793-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-08-18 |
| Published | 2015-09-30 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ecolab |
| Distribution | DC, PR |
Product
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 surgeries where warm irrigation, slush and/or cold solution are required.
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.
Identifiers
| code_info | ORS Fluid Warming Drape, 44" x 44" SKU # ORS-100: D112392, D112412, D112412A, D112921, D112932, D112942, D112972,…ORS Fluid Warming Drape, 44" x 44" SKU # ORS-100: D112392, D112412, D112412A, D112921, D112932, D112942, D112972, D112972A, D112982, D112992, D113002, D113002A, D113012, D113022, D113042, D113052, D113052A, D113062, D113072, D113082, D113082A, D113092, D113112, D113122, D113122A, D113132, D113132A, D113142, D113142A, D113152, D113152A, D113182, D113182A, D113192, D113202, D113202A, D113252, D113252A, D113262, D113262A, D113332, D113332A, D113342, D113342A, D113352, D113362, D113402, D113412, D113412A, D113422, D113432, D113462, D113462A, D113472, D113482, D113532, D113542, D113552, D113552A, D120032, D120042, D120122, D120142, D120162, D120172, D120442, D120452, D120462, D120472, D120492, D120512, D120522, D120532, D120552, D120562, D120582, D120592, D120622, D120652, D120662, D120662A, D120672, D120672A, D120682, D120692, D120692A, D120752, D120752A, D120792, D120792A, D120802, D120802A, D120812, D120812A, D120842, D120862, D120862A, D120872, D120872A, D120882, D120 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Other recalls by Ecolab
- Slush + Warmer Disc Drape
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Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2793-2015%22
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