Z-1677-2017Class II
Regard, Item Number: 800036004, Sterile, LD0274D - C Section Pack - FMOL St Francis
Resource Optimization & Innovation, LLC / initiated 2017-01-09 / Terminated / root cause: manufacturing process
Resource Optimization & Innovation Llc began a recall of Regard, Item Number: 800036004, Sterile, LD0274D - C Section Pack - FMOL St Francis on . FDA classified it as Class II and gives the reason as "Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field". As of , the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-1677-2017
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Resource Optimization & Innovation, LLC
- Product
- Regard, Item Number: 800036004, Sterile, LD0274D - C Section Pack - FMOL St Francis
- Product code
- LRO General Surgery Tray
- Reason for recall
- Custom procedure trays contain a component, a light glove, that has been recalled by the manufacturer because it can split during application to a light handle breaking the sterile field.
- Root cause tag
- manufacturing process
- FDA root cause
- Nonconforming Material/Component
- Action
- ROi sent an Urgent Recall Notice dated January 9, 2017, to all affected consignees. The recalling firm instructed consignees to quarantine affected product and complete the response form. The recalling firm stated that they will issue over lableing for the affected packs. Sterile replacement light covers will be sent directly to the end user if available. Consignees were instructed to inform their subaccounts of the recall. For questions regarding this recall call 417-820-2793.
- Quantity in commerce
- 670 kits
- Distribution
- US Distribution to LA and TX.
- Product codes and lots
- 026385D Exp Date 2017-07-13; 028105D Exp Date 2017-09-14; 029774D Exp Date 2017-12-04; 031980D Exp Date 2018-03-02; 033476D Exp Date 2018-05-10
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1544-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1545-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1546-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1547-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1548-201 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1549-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1550-201 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1551-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1552-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1553-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1554-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1555-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1556-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1557-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1558-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1559-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1560-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1561-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1562-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1563-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1564-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1565-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1566-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1567-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1568-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1569-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1570-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1571-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1572-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1573-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1574-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1575-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1576-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1577-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1578-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1579-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1580-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1581-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1582-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1583-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1584-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1585-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1586-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1587-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1588-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1589-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1590-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1591-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1592-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1593-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1594-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1595-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1596-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1597-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1598-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1599-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1600-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1601-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1602-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1603-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1604-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1605-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1606-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1607-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1608-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1609-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1610-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1611-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1612-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1613-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1614-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1615-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1616-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1617-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1618-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1619-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1620-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1621-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1622-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1623-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1624-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1625-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1626-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1627-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1628-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1629-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1630-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1631-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1632-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1633-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1634-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1635-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1636-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1637-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1638-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1639-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1640-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1641-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1642-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1643-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1644-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1645-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1646-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1647-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1648-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1649-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1650-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1651-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1652-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1653-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1654-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1655-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1656-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1657-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1658-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1659-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1660-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1661-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1662-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1663-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1664-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1665-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1666-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1667-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1668-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1669-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1670-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1671-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1672-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1673-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1674-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1675-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1676-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1677-2017 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1678-2017 | Class II | Terminated | Voluntary: Firm initiated |
FIRST ARTICLE / WEEKLY
What cleared, what was recalled, and what changed in the standards. One edition a week for the people who make medical devices.