Z-1621-2022Class II
METREX RESEARCH CORP SPONGE, METRISPONGE W/METRIZYME (25/BX 4BX/CS) Model Number: 10-4025
Mckesson Medical-Surgical Inc. Corporate Office / initiated 2022-05-25 / Open, Classified / root cause: manufacturing process
Mckesson Medical-Surgical Inc. Corporate Office began a recall of METREX RESEARCH CORP SPONGE, METRISPONGE W/METRIZYME (25/BX 4BX/CS) Model Number: 10-4025 on . FDA classified it as Class II and gives the reason as "Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21". As of , the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-1621-2022
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Mckesson Medical-Surgical Inc. Corporate Office
- Product
- METREX RESEARCH CORP SPONGE, METRISPONGE W/METRIZYME (25/BX 4BX/CS) Model Number: 10-4025
- Product code
- MNL Accessories, Cleaning Brushes, For Endoscope
- Reason for recall
- Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.
- Root cause tag
- manufacturing process
- FDA root cause
- Environmental control
- Action
- Mckesson Letter Notifcations issued via USP by or by email if available by the following third-party recall company: Sedgwick Brand Protection (formerly Stericycle) Sedgwick, Memphis, TN 38120 [email protected]. from May 10, 2022 continuing through July 21, 2022. Letter states: If you have further distributed this product, please notify your patients at once of this product recall. Your notification to your patients may be enhanced by including a copy of this recall notification letter. This recall should be carried out to the user level. Your assistance is appreciated and necessary to prevent possible patient harm. Please complete and return the enclosed response form as soon as possible even if you do not have any product on hand. Customers should contact Sedgwick directly by phone at 1-888-943-2401 to return the recalled products or if they have additional questions regarding this notification. Representatives are available Monday Friday, 8:00 am 5:00 pm PT
- Quantity in commerce
- 5 Boxes
- Distribution
- US Nationwide
- Product codes and lots
- GTIN: 00615375006771; 00615375003671
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1583-2022 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1584-2022 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1585-2022 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1586-2022 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1587-2022 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1588-2022 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1589-2022 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1590-2022 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1591-2022 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1592-2022 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1593-2022 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1594-2022 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1595-2022 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1596-2022 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1597-2022 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1598-2022 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1599-2022 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1600-2022 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1601-2022 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1602-2022 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1603-2022 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1604-2022 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1605-2022 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1606-2022 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1607-2022 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1608-2022 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1609-2022 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1610-2022 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1611-2022 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1612-2022 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1613-2022 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1614-2022 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1615-2022 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1616-2022 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1617-2022 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1618-2022 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1619-2022 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1620-2022 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1621-2022 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1622-2022 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1623-2022 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1624-2022 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1625-2022 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1626-2022 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1627-2022 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1628-2022 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1629-2022 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1630-2022 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1631-2022 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1632-2022 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1633-2022 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1634-2022 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1635-2022 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1636-2022 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1637-2022 | Class II | Ongoing | Voluntary: Firm initiated |
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