Medline Procedure Kits Recalled for Leaking Sterile Solution Bottles
Medline is recalling 5,200 procedure kits with sterile solution bottles that may leak at the seal, potentially compromising sterility. Affected units were distributed nationwide 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 medical device recall involving sterile procedure kits with a defect that could compromise sterility and introduce contamination during patient procedures. No illnesses or injuries have been reported to date, but the hazard poses a clear risk of harm.
Plain-English summary
Medline Industries is recalling approximately 5,200 procedure kits due to a manufacturing defect affecting sterile water and sterile normal saline solution bottles. The bottles may leak at the interface between the peel-foil and bottle opening, which could allow non-sterile contamination and compromise the sterility required for medical procedures.
The affected products are: 1) Wound Care Tray, reference DYNDA1412A with Lot Number 23KBH040; 2) Laceration Tray, reference DYNDL1263A with Lot Number 23KBD401. These kits have been distributed nationwide throughout the United States, as well as internationally to Panama and Canada.
Patients and healthcare facilities using these kits should immediately discontinue use and contact Medline Industries for guidance on replacement or proper disposal. The leaking containers pose a risk to patient safety by potentially introducing contaminants during sterile procedures.
The recalled product
- Product
- Medline procedure kits, labeled as: 1) WOUND CARE TRAY, REF DYNDA1412A; 2) LACERATION TRAY, REF DYNDL1263A.
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- leak
- contamination
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 (4)
- 1) REF DYNDA1412A: UDI/DI 10193489693423 (EA) 40193489693424 (CS)
- Lot Numbers: 23KBH040
- 2) REF DYNDL1263A: UDI/DI 10884389347126 (EA) 40884389347127 (CS)
- Lot Numbers: 23KBD401.
Distribution
Distributed nationwide across the United States.
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