Medline sterile solution bottles recalled due to leaking seals
Medline is recalling procedure kits because the sterile water and saline bottles leak at the peel-foil seal. The recall affects 822 units distributed in the US, Panama, and Canada.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II classification with a defect affecting product sterility and integrity. No illnesses or injuries reported, placing this at the maximum score for theoretical hazards per the rubric.
Plain-English summary
Medline Industries is recalling six types of procedure kits that contain sterile water and sterile 0.9% normal saline bottles. The bottles have been identified as leaking at the interface between the peel-foil and bottle opening.
The recalled products are STERILE PREP KIT (REF DYNDA1359A), STRL EK SINGLE PACK (REF DYNDA1360B), SHEATH REMOVAL TRAY (REF DYNDC1311C), SENSITIVE SKIN WEEKLY VAD (REF DYNDC3185), NURSING SKILLS (REF EDUC05015A), and NURSING SUPPLY BAG (REF EDUC1024A). A total of 822 units have been distributed worldwide, with distribution to the US, Panama, and Canada.
The leak compromises product sterility and may result in product loss or contamination. Healthcare facilities and individuals who have received these products should stop using them and contact Medline Industries for replacement or additional guidance.
The recalled product
- 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 EDUC102
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- product-leakage
- sterility-compromise
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (15)
- 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.
Distribution
Distributed nationwide across the United States.
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