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Terminated

Liko Comfort Sling Plus Model 300, Part number 35300305, Size Medium, LIKO, Sweden. Liko a Hill-Rom Company. Enables a comfortable sitting position and adapts to the patient without the need for individual adjustments when transferring a patient with a lift.

FDA Recall Z-1396-2011 · Posted 2011-02-23

Recalling FirmHill-Rom, Inc.
Recall StatusTerminated
Product CodeFSA
Date Initiated2011-02-09
Date Terminated2011-10-07
Product Quantity10 units

Reason for Recall

Slings were improperly assembled and the loops that are used to support the sling when hung from a lift were too long, potentially putting the patient being lifted at risk of falling out.

Firm Action

The firm sent an URGENT MEDICAL DEVICE RECALL notice dated 02/09/2011 to Facility Risk Manager/Facility Administrators. The letter Identified the affected product, explained the recall situation, and asked firms to check their facility for the affected serial numbers. Consignees were asked to return the recalled products, and a replacement sling would be sent to them. Customers can contact Hill-Rom Technical Support at 800-445-3720, if they have any questions concerning this matter.

Root Cause

Pending

Distribution Pattern

Worldwide Distribution -- US, Switzerland, Germany, Denmark, Finland, France, UK, Italy, Netherlands, Sweden, and Canada.

Official Source

View FDA Recall →

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

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