Medline Wound Care and Laceration Procedure Kits Recalled for Leaking Bottles
Medline is recalling Sterile Water and Sterile 0.9% Normal Saline bottles in wound care and laceration procedure kits due to leaking at the peel-foil and bottle opening interface.
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: This is a Class II recall involving a defect that could affect sterile medical products used in wound care and laceration repair. Although no illnesses or injuries are reported in the source, the potential for contamination of sterile solutions represents a risk of harm in a medical context.
Plain-English summary
Medline Industries, LP is recalling approximately 5,200 units of two procedure kit products: the Wound Care Tray (REF DYNDA1412A) and the Laceration Tray (REF DYNDL1263A). The recall affects products distributed nationwide in the United States as well as in Panama and Canada.
The Sterile Water and Sterile 0.9% Normal Saline bottles in these kits have been found to leak at the interface where the peel-foil meets the bottle opening. This defect may compromise the sterility of the solutions contained within.
Consumers and healthcare facilities that have received these products should stop using them and contact Medline Industries, LP for replacement or further guidance. The affected lot numbers are 23KBH040 for the Wound Care Tray and 23KBD401 for the Laceration Tray.
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
- Affected units
- 5,200
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.
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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