Z-1527-2019Class II
Maquet Getinge-BEQ-TOP 33500 3/8" ECC PACK Material: 701053752
Maquet Cardiovascular LLC / initiated 2019-04-18 / Terminated / root cause: design
Maquet Cardiovascular, LLC began a recall of Maquet Getinge-BEQ-TOP 33500 3/8" ECC PACK Material: 701053752 on . FDA classified it as Class II and gives the reason as "Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed...". As of , the recall status on record is Terminated, and MDM tags the root cause as design.
Recall record
- Recall number
- Z-1527-2019
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Maquet Cardiovascular LLC
- Product
- Maquet Getinge-BEQ-TOP 33500 3/8" ECC PACK Material: 701053752
- Product code
- DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
- Reason for recall
- Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
- Root cause tag
- design
- FDA root cause
- Device Design
- Action
- Maquet Getinge issued recall notification letter on April 18, 2019 via FedEx 2-day delivery identifies issue, health risk and action to take: quarantine and return to Maquet/Getinge recalled product. Complete response form and return to acknowledge this recall. Questions contact Getinge Customer Service at 1 888 627 8383 (press option 2, then option 2) between the hours of 8 AM and 6 PM Eastern Standard Time. On 3/26/20 firm expanded recall to include an additional lot for one consignee,product: "BEQ TOP 25003 3/8 3/8 up to 7 lpm", item number 701063255R02, lot 3000087051.
- Distribution
- Nationwide
- Product codes and lots
- Batch Numbers: 3000056255
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1498-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1499-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1500-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1501-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1502-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1503-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1504-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1505-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1506-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1507-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1508-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1509-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1510-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1511-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1512-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1513-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1514-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1515-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1516-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1517-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1518-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1519-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1520-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1521-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1522-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1523-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1524-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1525-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1526-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1527-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1528-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1529-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1530-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1531-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1532-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1533-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1534-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1535-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1536-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1537-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1538-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1539-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1540-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1541-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1542-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1543-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1544-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1545-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1546-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1547-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1548-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1549-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1550-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1551-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1552-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1553-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1554-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1555-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1556-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1557-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1558-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1559-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1560-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1561-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1562-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1563-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1564-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1565-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1566-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1567-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1568-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1569-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1570-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1571-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1572-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1573-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1574-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1575-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1576-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1577-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1578-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1579-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1580-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1581-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1582-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1583-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1584-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1585-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1586-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1587-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1588-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1589-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1590-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1591-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1592-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1593-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1594-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1595-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1596-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1597-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1598-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1599-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1600-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1601-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1602-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1603-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1604-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1605-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1606-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1607-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1608-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1609-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1610-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1611-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1612-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1613-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1614-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1615-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1616-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1617-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1618-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1619-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1620-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1621-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1622-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1623-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1624-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1625-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1626-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1627-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1628-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1629-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1630-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1631-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1632-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1633-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1634-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1635-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1636-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1637-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1638-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1639-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1640-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1641-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1642-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1643-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1644-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1645-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1646-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1647-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1648-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1649-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1650-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1651-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1652-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1653-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1654-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1655-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1656-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1657-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1658-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1659-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1660-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1661-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1662-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1663-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1664-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1665-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1666-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1667-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1668-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1669-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1670-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1671-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1672-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1673-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1674-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1675-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1676-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1677-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1678-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1679-2019 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1680-2019 | 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.