Z-0781-2025Class II
Medline custom medical procedure kits labeled as: 1) NASAL PACK, REF DYNJ67789A
MEDLINE INDUSTRIES, LP - Northfield / initiated 2024-11-21 / Open, Classified / root cause: manufacturing process
MEDLINE INDUSTRIES, LP - Northfield began a recall of Medline custom medical procedure kits labeled as: 1) NASAL PACK, REF DYNJ67789A on . FDA classified it as Class II and gives the reason as "Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination". As of , the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-0781-2025
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product
- Medline custom medical procedure kits labeled as: 1) NASAL PACK, REF DYNJ67789A.
- Product code
- MMO Tray, Surgical, Ent
- Reason for recall
- Custom convenience kits are being recall because the contain non-sterile Codman Surgical Patties & Surgical Strips, which have the potential for endotoxin contamination.
- Root cause tag
- manufacturing process
- FDA root cause
- Nonconforming Material/Component
- Action
- Medline issued a MEDICAL DEVICE VOLUNTARY RECALL notice on 11/21/2024 to its consignees via US Mail and email. The notice explained the issue, potential risk to health, and requested that the affected product be quarantined. Once the response is received, Medline will provide labels to place on affected inventory, with instructions for the consignee to remove the affected component prior to using the kit.
- Quantity in commerce
- 80 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of UAE, and Canada.
- Product codes and lots
- 1) REF DYNJ67789A, UDI/DI 10193489945645 (EA) 40193489945646 (CS), Lot Numbers: 21GBW066, 21JBK474, 21KBS434, 21KBX401
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-0777-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0778-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0779-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0780-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0781-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0782-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0783-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0784-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0785-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0786-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0787-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0788-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0789-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0790-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0791-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0792-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0793-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-0794-2025 | 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.