Z-1141-2021Class II

Slush + Warmer Disc Drape; Model ORS-320 Slush + Warmer Disc Drapes -

Name: Z-1141-2021 Slush + Warmer Disc Drape; Model ORS-320 Slush + Warmer Disc Drapes -
Creator: Ecolab Inc
Published: 2021-01-11
License: https://open.fda.gov/license/

Microtek Medical LLC / initiated 2021-01-11 / Terminated / root cause: manufacturing process

FDA source

Ecolab Inc began a recall of Slush + Warmer Disc Drape; Model ORS-320 Slush + Warmer Disc Drapes - Product Usage: single-use equipment cover intended for use during various surgeries where... on 2021-01-11. FDA classified it as Class II and gives the reason as "Slits were identified in a low quantity of ORS-320 Slush + Warmer Disc Drapes from a single lot. A source for potential manufacturing error was identified and investigation is underway to prevent further recurrence. The...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1141-2021
Classification: Class II
Status: Terminated
Initiated: 2021-01-11
Posted: 2021-02-22
Terminated: 2023-01-09
Recalling firm: Microtek Medical LLC
Product: Slush + Warmer Disc Drape; Model ORS-320 Slush + Warmer Disc Drapes - Product Usage: single-use equipment cover intended for use during various surgeries where warm irrigation, slush and/or cold solution is required.
Product code: PUI Drape, Surgical, Exempt
Reason for recall: Slits were identified in a low quantity of ORS-320 Slush + Warmer Disc Drapes from a single lot. A source for potential manufacturing error was identified and investigation is underway to prevent further recurrence. The slits may lead to a breach in the sterile barrier between fluid in the basin and the slush/warming equipment. This could pose a risk of infection to patients receiving warmed irrigation fluid or surgical slush if used during a procedure.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: The firm sent a recall communication letter "Urgent: MEDICAL DEVICE RECALL IMMEDIATE ATTENTION REQUIRED" to customers on 01/11/2021.
Quantity in commerce: 132 cases (3168 drapes)
Distribution: Worldwide distribution - US Nationwide Distribution in the states of AL, AZ, CA, CO, FL, HI, ID, IL, IN, KS, LA, MA, MD, MI, MO, MT, NJ, NY, OH, OK, OR, PA, TN, TX, UT, WA. In the country of Japan.
Product codes and lots: Model ORS-320, lot D192619A, 132 cases (3168 drapes)

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1141-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1141-2021	Class II	Terminated	Voluntary: Firm initiated	2021-03-03	2021-02-22

Product code PUI

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)