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Terminated

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 Recall Z-1210-2014 · Posted 2014-03-14

Recalling FirmDeRoyal Industries Inc
Recall StatusTerminated
Product CodeFMQ
Date Initiated2014-02-21
Date Terminated2015-05-08
Product Quantity8,962 pairs

Reason for Recall

Moldy smell in product

Firm Action

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.

Root Cause

Packaging

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K963476DISPOSABLE LIMB HOLDERDeroyal Industries, Inc. · 1997-01-22

Official Source

View FDA Recall →

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

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