Medline Plastics Suture Tray recalled due to leaking sterile liquid bottles
Medline is recalling Plastics Suture Tray kits (Ref SUT13535) because the included Sterile Water and Sterile 0.9% Normal Saline bottles leak at the peel-foil and bottle opening interface.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall. The source does not report any illnesses, injuries, or confirmed adverse events—only a potential for harm from leaking bottles in a sterile procedure kit. The defect is a packaging/functionality issue with no reported clinical impact, meeting the criterion for Moderate severity.
Plain-English summary
Medline Industries, LP is recalling Plastics Suture Tray procedure kits, labeled as REF SUT13535, due to leaking Sterile Water and Sterile 0.9% Normal Saline bottles. The bottles leak at the interface where the peel-foil meets the bottle opening.
The recalled kits have UDI/DI 10653160144250 (EA) and 40653160144251 (CS), with Lot Number 23JBU525. A total of 120 units were distributed worldwide, including distribution across the United States, Panama, and Canada.
Leaking sterile solutions in a medical procedure kit may compromise the sterility and integrity of the contents, potentially affecting the safety of surgical procedures. Consumers and healthcare facilities should stop using the recalled kits and contact Medline for instructions on return or replacement.
The recalled product
- Product
- Medline procedure kits, labeled as: PLASTICS SUTURE TRAY, REF SUT13535
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 120
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 (2)
- UDI/DI 10653160144250 (EA) 40653160144251 (CS)
- Lot Numbers: 23JBU525
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 10 recalled by MEDLINE INDUSTRIES, LP - Northfield under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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