DeRoyal(R) LIMB HOLDERS, COTTON ADJUSTABLE, UNIVERSAL, REF M2017 Product Usage: Limb holders are intended for mildly to
FDA device recall Z-1210-2014 · posted 2014-03-14 · Terminated
Recall details
- Recalling firm
- DeRoyal Industries Inc
- Reason for recall
- Moldy smell in product
- Action taken
- 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
- Status
- Terminated
- Product code
- FMQ
- Quantity affected
- 8,962 pairs
- Distribution
- Worldwide Distribution - USA Nationwide in the states of FL, NC, IA, AL, IL, TX and the countries of Argentina.
- Date initiated
- 2014-02-21
- Date posted
- 2014-03-14
- Date terminated
- 2015-05-08
- Location
- Powell, TN
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DISPOSABLE LIMB HOLDER (K963476) | Deroyal Industries, Inc. | 1997-01-22 |