Recall record at a glance
| Official record | Z-1141-2021 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Ecolab Inc. |
| Report date | Mar 3, 2021 |
| Recall initiation date | Jan 11, 2021 |
| Quantity | 132 cases (3168 drapes) |
| Location | Saint Paul, MN, United States |
Official product description
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.
Why the product was recalled
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.
Distribution information
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.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: N/A.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
Recall Lookup USA preserves the most complete source information successfully retrieved. We do not create missing facts or infer affected lots or VINs. The official record may still change, so use the identifier above when verifying current instructions.
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