Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 2 Device Recall Hill Rom

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 2 Device Recall Hill Rom see related information
Date Initiated by Firm August 11, 2021
Create Date September 30, 2021
Recall Status1 Open3, Classified
Recall Number Z-2600-2021
Recall Event ID 88548
Product Classification Lift, patient, non-ac-powered - Product Code FSA
Product LikoStretch 1900 Model Number: 3156051 - The combination of this products allows the user to easily adjust/control the center of gravity during lift of patient.
Code Information N/A
Recalling Firm/
Manufacturer		 Hill-Rom, Inc.
1069 State Road 46 E
Batesville IN 47006-7520
For Additional Information Contact Howard Karesh Chicago, Illinois 312
312-237-6188
Manufacturer Reason
for Recall		 Stretch Leveller has the potential to lose the function of maintaining a patient in the horizontal position when lifting and in motion. When this function is lost the patient can slide backwards and potentially may fall out of the Oct lift sheet back onto the surface it is being lifted from.
FDA Determined
Cause 2		 Under Investigation by firm
Action Hillrom issued URGENT Medical Device Correction letter dated August 11, 2021 by third party vendor via UPS mail/track the delivery to consignees. Letter states reason for recall, health risk and action to take: Hillrom is initiating this Medical Device Correction to all customers and will be correcting devices with an updated to the leveller. Actions being taken by Customer: Please share this Medical Device Correction with all potential users in your organization. Please ensure inspection of the device prior to use as stated in the device Instruction for Use (IFU). Complete the attached response form, acknowledging receipt, indicate the number of devices and return to hillromLUL003@stericycle.com within one month
Quantity in Commerce 9 units
Distribution Worldwide distribution - US Nationwide distribution in the states of AZ, CA, CO, DE, IL, ME, MI, MO, MS, NJ, OH, PA, VA, WA and the countries of Argentina, Australia, Austria, Bolivia, Canada, China, Colombia, Costa Rica, Croatia, Czech Republic, Denmark, Finland, France, Germany, Great Britain, Greece, Hong Kong, India, Ireland, Italy, Japan, Jordan, Kuwait, Latvia, Lithuania, Mexico, Netherlands, Norway, Poland, Portugal, Serbia, Slovakia, Spain, Sweden, Switzerland, Taiwan, Province of China, Thailand, Turkey, United Arab Emirates.
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
-
-