Device 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
Z-1210-2014
Product summary
- Event
- Event 67686
- Status
- Terminated
- Classification
- Class II
- Quantity
- 8,962 pairs
- Official record key
device-enforcement:Z-1210-2014
Official wording
Reason: Moldy smell in product
Code information: lot numbers 1143442 and 1161762
Distribution pattern: Worldwide Distribution - USA Nationwide in the states of FL, NC, IA, AL, IL, TX and the countries of Argentina.
Derived failure modes
-
Unknown
Moldy smell in product