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Open, Classified

OctoStretch with Stretch Leveller - The combination of this products allows the user to easily adjust/control the center of gravity during lift of patient. Model Number: 3156056

FDA Recall Z-2597-2021 · Posted None

Recalling FirmHill-Rom, Inc.
Recall StatusOpen, Classified
Product CodeFSA
Date Initiated2021-08-11
Product Quantity440 units

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.

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 [email protected] within one month

Root Cause

Under Investigation by firm

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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