SVS LLC began a recall of PremierPro Aluminum Adjustable Walker on . FDA classified it as Class II and gives the reason as "This recall is due to a mandated order from the FDA for stock recovery and return of the imported item". As of , the recall status on record is Terminated.
Recall record
- Recall number
- Z-0487-2019
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- SVS LLC
- Product
- PremierPro Aluminum Adjustable Walker
- Product code
- ITJ Walker, Mechanical
- Reason for recall
- This recall is due to a mandated order from the FDA for stock recovery and return of the imported item.
- FDA root cause
- Other
- Action
- SVS LLC, dba S2S Global notified customers initially via telephone on about 10/01/2018 and followed up with a "Notice of Product Recall" letter on about 10/03/2018. The letter requested customers check inventory for affected walkers, quarantine any on hand, make arrangements to return the affected walkers, and complete and return the Medical Device Acknowledgement & Return Response Form.
- Quantity in commerce
- 256 devices
- Distribution
- US distribution to OH, NY,TX, PA
- Product codes and lots
- Model 7803. Lot number:: CJH05041. Serial number: J1805000577-J1805000864
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0487-2019 | Class II | Terminated | Voluntary: Firm initiated |
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