Z-1612-2025Class II
Medline Convenience kits used for various procedures: 1) CW PERI GYN, Model Number: DYNJ80807B
MEDLINE INDUSTRIES, LP - Northfield / initiated 2025-03-03 / Open, Classified / root cause: packaging
MEDLINE INDUSTRIES, LP - Northfield began a recall of Medline Convenience kits used for various procedures: 1) CW PERI GYN, Model Number: DYNJ80807B on . FDA classified it as Class II and gives the reason as "There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits". As of , the recall status on record is Open, Classified, and MDM tags the root cause as packaging.
Recall record
- Recall number
- Z-1612-2025
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product
- Medline Convenience kits used for various procedures: 1) CW PERI GYN, Model Number: DYNJ80807B
- Product code
- MLT Pelvic Exam Kit
- Reason for recall
- There is a potential for open/weak seals on purchased breather pouches used for packaging of select sterile convenience kits.
- Root cause tag
- packaging
- FDA root cause
- Under Investigation by firm
- Action
- An IMMEDIATE ACTION REQUIRED MEDLINE DEVICE RECALL notification letter dated 3/3/25 was sent to customers. REQUIRED ACTION: 1.Immediately check your stock for the affected item number and the affected lot numbers which can be located within the recall portal. 2.Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the response form. 3.Please destroy any affected inventory. Medline will issue credit for the product based upon the quantity and lot numbers identified on the submitted response form The login for completing the response form is: Website link: https://recalls.medline.com Recall Reference #: R-25-050-FG Recall Code: RECALL CODE 4.If you are a distributor, or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication. Please request that customers document and destroy any affected product, and include your customer s quantities on your response form. If you have any questions, contact the Recall Department at 866-359-1704 or [email protected].
- Quantity in commerce
- 48 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Canada, Mexico, Panama, Virgin Islands.
- Product codes and lots
- 1) DYNJ80807B, UDI-DI: 10195327415624(each), 40195327415625(case), Lot Number: 24IBH993
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1586-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1587-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1588-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1589-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1590-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1591-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1592-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1593-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1594-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1595-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1596-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1597-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1598-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1599-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1600-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1601-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1602-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1603-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1604-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1605-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1606-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1607-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1608-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1609-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1610-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1611-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1612-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1613-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1614-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1615-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1616-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1617-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1618-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1619-2025 | 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.