—#126065

Product

DeRoyal(R) LIMB HOLDERS, COTTON ADJUSTABLE, UNIVERSAL, REF M2017 Product Usage: Limb holders are intended for mildly to moderate agitated or disoriented patients who disrupt medical treatment and/or cause harm to themselves and/or others

FDA product code: FMQ — Restraint, Protective
Device class: Class 1
Medical specialty: General Hospital
510(k) numbers: K963476
Affected lot / code info: lot numbers 1143442 and 1161762

Why it was recalled

Moldy smell in product

Root cause (FDA determination)

Packaging

Action the firm took

DeRoyal initiated an Urgent Voluntary Recall dated February 21, 2014 to all affected customers. The letter identified the affected product, problem and actions to be taken. DeRoyal has asked that products be destroyed, and that notice of destruction be sent back. For questions contact your DeRoyal Sales Representative or DeRoyal Customer Service at 1-800-251-9864.

Recalling firm

Firm: DeRoyal Industries Inc
Address: 200 Debusk Ln, Powell, Tennessee 37849-4703

Distribution

Distribution pattern: Worldwide Distribution - USA Nationwide in the states of FL, NC, IA, AL, IL, TX and the countries of Argentina.

Timeline

Recall initiated: 2014-02-21
Posted by FDA: 2014-03-14
Terminated: 2015-05-08
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #126065. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.