Z-2445-2026Class II
Medline convenience kits: ADD-A-CATH ARTERIAL INSERTION ARTNC185 PED SCHOOL AGE PICC DRSG TRAY DYNDC3291
MEDLINE INDUSTRIES, LP - Northfield / initiated 2026-04-27 / Open, Classified / root cause: manufacturing process
Medline Industries, LP began a recall of Medline convenience kits: ADD-A-CATH ARTERIAL INSERTION ARTNC185 PED SCHOOL AGE PICC DRSG TRAY DYNDC3291 on . FDA classified it as Class II and gives the reason as "Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application". As of , the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.
Recall record
- Recall number
- Z-2445-2026
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product
- Medline convenience kits: ADD-A-CATH ARTERIAL INSERTION ARTNC185 PED SCHOOL AGE PICC DRSG TRAY DYNDC3291
- Product code
- OFF Central Venous Catheter Tray
- Reason for recall
- Kits contain recalled lot of Ferndale Laboratories MASTISOL Liquid Adhesive. Butyrate tubing may crack during actuation and render product unusable for application.
- Root cause tag
- manufacturing process
- FDA root cause
- Process control
- Action
- Firm began notifying consignees on 4/27/2026. Customers were instructed to request stickers to over-label affected convenience kits with a warning label. Warning label indicates for user to remove the affected component and replace it with product from supply. No kits are to be returned.
- Quantity in commerce
- 49,654 kits total
- Distribution
- US Nationwide distribution. OUS distribution pending.
- Product codes and lots
- ARTNC185 UDI-DI 10195327640729 Lot 25JBU463 DYNDC3291 UDI-DI 10195327334741 Lot 25KBH082
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-2414-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2415-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2416-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2417-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2418-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2419-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2420-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2421-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2422-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2423-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2424-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2425-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2426-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2427-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2428-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2429-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2430-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2431-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2432-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2433-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2434-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2435-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2436-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2437-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2438-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2439-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2440-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2441-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2442-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2443-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2444-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2445-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2446-2026 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-2447-2026 | Class II | Ongoing | Voluntary: Firm initiated |
FIRST ARTICLE / WEEKLY
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