Z-1590-2022Class II
a. Alcon Clear Care Contact Lens Solution Clear Care 12 oz. Solution, Model Number: 65035820, Model Number...
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 a. Alcon Clear Care Contact Lens Solution Clear Care 12 oz. Solution, Model Number: 65035820, Model Number: USSCupA-12BUP300. b. Alcon Contact Lens Solution... 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-1590-2022
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- Mckesson Medical-Surgical Inc. Corporate Office
- Product
- a. Alcon Clear Care Contact Lens Solution Clear Care 12 oz. Solution, Model Number: 65035820, Model Number: USSCupA-12BUP300. b. Alcon Contact Lens Solution Opti Free Replenish 4 oz. Solution Model Number: 00065035604 Model Number: USSCupA-12BUP300. c. Alcon Contact Lens Solution Opti Free Replenish 10 oz. Solution Model Number: 00065035610. d. Alcon Contact Lens Solution Opti Free Replenish 2 oz. Solution Model Number: 00065135658.
- Product code
- LPN Accessories, Soft Lens Products
- 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
- a. 3 b. 91 c. 45 d. 2
- Distribution
- US Nationwide
- Product codes and lots
- a. GTIN: 00047113609126 EA; 20300650358204 CS. All lots received between 7/4/21-9/30/21. b. GTIN: 00300650356350 EA; 20300650356354 CS All lots received between 7/4/21-9/30/21. c. GTIN: 00300650356107 EA; 20300650357207 CS All lots received between 7/4/21-9/30/21. d. GTIN: 00300651356380 EA, 20300650357399 CS All lots received between 7/4/21-9/30/21
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 |
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.