Z-1709-2025Class II
Medline procedure kits, labeled as: 1) STERILE PREP KIT, REF DYNDA1359A; 2) STRL EK SINGLE PACK, REF...
MEDLINE INDUSTRIES, LP - Northfield / initiated 2025-03-19 / Open, Classified / root cause: sterility
MEDLINE INDUSTRIES, LP - Northfield began a recall of Medline procedure kits, labeled as: 1) STERILE PREP KIT, REF DYNDA1359A; 2) STRL EK SINGLE PACK, REF DYNDA1360B; 3) SHEATH REMOVAL TRAY, REF DYNDC1311C; 4)... on . FDA classified it as Class II and gives the reason as "It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening". As of , the recall status on record is Open, Classified, and MDM tags the root cause as sterility.
Recall record
- Recall number
- Z-1709-2025
- Classification
- Class II
- Status
- Open, Classified
- Initiated
- Posted
- Recalling firm
- MEDLINE INDUSTRIES, LP - Northfield
- Product
- Medline procedure kits, labeled as: 1) STERILE PREP KIT, REF DYNDA1359A; 2) STRL EK SINGLE PACK, REF DYNDA1360B; 3) SHEATH REMOVAL TRAY, REF DYNDC1311C; 4) SENSITIVE SKIN WEEKLY VAD, REF DYNDC3185; 5) NURSING SKILLS, REF EDUC05015A; 6) NURSING SUPPLY BAG, REF EDUC1024A.
- Product code
- LRO General Surgery Tray
- Reason for recall
- It was identified that the Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles were leaking at the interface of the peel-foil and bottle opening.
- Root cause tag
- sterility
- FDA root cause
- Under Investigation by firm
- Action
- Medline Industries issued an IMMEDIATE ACTION REQUIRED recall notice to its consignees on 03/19/2025 via email and US mail. The notice explained the issue, potential risk and requested all affected product be destroyed. Credit will be issued upon receipt of completed destruction form. Those who have transferred or further distributed the product were directed to notify those to whom the product was transferred or distributed. For questions contact 866-359-1704 or email [email protected].
- Quantity in commerce
- 822 units
- Distribution
- Worldwide distribution - US Nationwide and the countries of Panama and Canada.
- Product codes and lots
- 1) REF DYNDA1359A: UDI/DI 10195327417734 (EA) 40195327417735 (CS), Lot Numbers: 23KBW508; 2) REF DYNDA1360B: UDI/DI 10889942903863 (EA) 40889942903864 (CS), Lot Numbers: 23KBB406; 3) REF DYNDC1311C: UDI/DI 10080196151561 (EA) 40080196151562 (CS), Lot Numbers: 23KBX338; 4) REF DYNDC3185: UDI/DI 10195327034108 (EA) 40195327034109 (CS), Lot Numbers: 23KBX632; 5) REF EDUC05015A: UDI/DI 10193489849035 (EA) 40193489849036 (CS), Lot Numbers: 23LDA746, 23LDA814, 23LDA218; 6) REF EDUC1024A: UDI/DI 10195327493165 (EA) 40195327493166 (CS), Lot Numbers: 23LDA281, 23KDA001.
Enforcement reports
One row per recalled product line| Recall number | Class | Status | Voluntary or mandated | Report date | Classified |
|---|---|---|---|---|---|
| Z-1705-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1706-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1707-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1708-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1709-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1710-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1711-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1712-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1713-2025 | Class II | Ongoing | Voluntary: Firm initiated | ||
| Z-1714-2025 | 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.