| Class 2 Device Recall LikoStretch Mod 600 IC | |
Date Initiated by Firm | August 11, 2021 |
Create Date | September 30, 2021 |
Recall Status1 |
Open3, Classified |
Recall Number | Z-2601-2021 |
Recall Event ID |
88548 |
Product Classification |
Lift, patient, non-ac-powered - Product Code FSA
|
Product | LikoStretch Mod 600 IC Model Number: 3156065
LikoStretch Mod 600 IC, Wide Model Number: 3156065B (obsolete since 12JUN2020) - The combination of this products allows the user to easily adjust/control the center of gravity during lift of patient. |
Code Information |
N/A
LikoStretch Mod 600 IC, Wide 3156065B UDI: 0887761GMN000036U9 |
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 | Undetermined |
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.
|
|
|
|