Recall Z-1210-2014— DeRoyal Industries Inc

Name: FDA recall Z-1210-2014
Creator: U.S. Food and Drug Administration
Published: 2014-02-21

Class II · Terminated

Class II FDA medical device recall by DeRoyal Industries Inc, initiated 2014-02-21, terminated 2015-05-08. It names one FDA 510(k) clearance: K963476. 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. Reason: Moldy smell in product.

Recalling firm: DeRoyal Industries Inc
Classification: Class II
Status: Terminated
Initiated: 2014-02-21
Terminated: 2015-05-08
Firm location: Powell, TN, United States

510(k) clearances named in this recall

1 on FDA's record

K963476 — DISPOSABLE LIMB HOLDERDeroyal Industries, Inc.·cleared 1997-01-22

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

Moldy smell in product

Data sourced from openFDA. This site is unofficial and independent of the FDA.