Recall Z-1210-2014 ยท FMQ Restraint, Protective
DeRoyal Industries Inc
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
| Date | Mar 14, 2014 (initiated Feb 21, 2014) |
| Status | Terminated |
| Reason | Moldy smell in product |
| Root cause | Packaging |
| 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. |
| Quantity | 8,962 pairs |
| Distribution | Worldwide Distribution - USA Nationwide in the states of FL, NC, IA, AL, IL, TX and the countries of Argentina. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K963476 | DISPOSABLE LIMB HOLDER Deroyal Industries, Inc., Jan 22, 1997 |