Z-1487-2016Class II
Catalog Number: 900774 INCISION AND DRAINAGE TRAY Used by medical staff to perform surgical procedures and...
Customed, Inc / initiated 2016-01-07 / Terminated / root cause: packaging
Customed, Inc began a recall of Catalog Number: 900774 INCISION AND DRAINAGE TRAY Used by medical staff to perform surgical procedures and patient care procedures such as wound healing... on . FDA classified it as Class II and gives the reason as "Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile". As of , the recall status on record is Terminated, and MDM tags the root cause as packaging.
Recall record
- Recall number
- Z-1487-2016
- Classification
- Class II
- Status
- Terminated
- Initiated
- Posted
- Terminated
- Recalling firm
- Customed, Inc
- Product
- Catalog Number: 900774 INCISION AND DRAINAGE TRAY Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc.
- Product code
- LRO General Surgery Tray
- Reason for recall
- Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
- Root cause tag
- packaging
- FDA root cause
- Packaging
- Action
- Recall Notification Letter sent to direct accounts via certified mail with return receipt on January 7, 2016 and January 8, 2016.
- Quantity in commerce
- 800
- Distribution
- Distributed only in Puerto Rico.
- Product codes and lots
- LOTS: SL15177 (150619315) 30-JUN-16 SL15268 (150719854) 30-SEP-16 SL15271 (150719854) 30-SEP-16
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1397-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1398-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1399-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1400-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1401-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1402-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1403-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1404-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1405-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1406-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1407-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1408-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1409-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1410-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1411-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1412-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1413-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1414-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1415-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1416-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1417-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1418-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1419-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1420-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1421-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1422-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1423-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1424-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1425-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1426-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1427-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1428-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1429-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1430-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1431-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1432-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1433-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1434-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1435-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1436-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1437-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1438-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1439-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1440-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1441-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1442-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1443-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1444-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1445-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1446-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1447-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1448-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1449-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1450-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1451-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1452-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1453-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1454-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1455-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1456-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1457-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1458-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1459-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1460-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1461-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1462-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1463-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1464-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1465-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1466-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1467-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1468-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1469-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1470-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1471-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1472-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1473-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1474-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1475-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1476-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1477-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1478-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1479-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1480-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1481-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1482-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1483-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1484-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1485-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1486-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1487-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1488-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1489-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1490-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1491-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1492-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1493-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1494-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1495-2016 | Class II | Terminated | Voluntary: Firm initiated | ||
| Z-1496-2016 | 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.