| Class 2 Device Recall Slush Warmer Disc Drape | |
Date Initiated by Firm | January 11, 2021 |
Create Date | February 22, 2021 |
Recall Status1 |
Terminated 3 on January 09, 2023 |
Recall Number | Z-1141-2021 |
Recall Event ID |
87173 |
Product Classification |
Drape, surgical, exempt - Product Code PUI
|
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. |
Code Information |
Model ORS-320, lot D192619A, 132 cases (3168 drapes) |
Recalling Firm/ Manufacturer |
Ecolab Inc 1 Ecolab Pl Saint Paul MN 55102-2739
|
For Additional Information Contact | Roman Blahoski 651-250-4385 |
Manufacturer 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. |
FDA Determined Cause 2 | 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. |
Total Product Life Cycle | TPLC Device Report |
|
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls. 2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall. 3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
|
|
|
|