Recall Z-2793-2015— Ecolab Inc
Class II · Terminated
Class II FDA medical device recall by Ecolab Inc, initiated 2015-08-18, terminated 2017-08-09. It names 3 FDA 510(k) clearances: K142080, K023282, K021288. 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..
- Recalling firm
- Ecolab Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-08-18
- Terminated
- 2017-08-09
- Firm location
- Saint Paul, MN, United States
510(k) clearances named in this recall
3 on FDA's record- K142080 — NON-STERILE ORS WARNING DRAPES/SLUSH+WARMER DISC-DRAPE/SLUSH+WARMER PALTE-DRAPE /FLUID WARMER DRAPE,SKIRTED
- K023282 — ORS-3000LD
- K021288 — ORS-1000LD
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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 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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.