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Terminated

Arjo Disposable Repositioning Sling, Model AHD001

FDA Recall Z-2470-2021 · Posted None

Recalling FirmGetinge Dominican Republic SA
Recall StatusTerminated
Product CodeFSA
Date Initiated2021-07-30
Date Terminated2023-08-11
Product Quantity46,085 units

Reason for Recall

Sling loop straps on device pose a trip hazard.

Firm Action

The Field Safety Notification (FSN) will be accompanied by a Customer Response Form. The customer will be asked to acknowledge the FSN reception, complete and sign an enclosed Customer Response Form and return it to the local Arjo office (address indicated in the FSN) in order to confirm that the caution and additionally provided instructions are understood and followed by personnel.

Root Cause

Device Design

Distribution Pattern

US Nationwide distribution in the states of AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, MD, ME, MI, MN, MO, MS, NC, ND, NJ, NM, NY, OH, OR, PA, SC, TN, TX, VA, VT, WI, and WV.

Official Source

View FDA Recall →

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

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