Medline Sterile Water and Saline Procedure Kits Recalled for Leaking Bottles
Medline Industries is recalling 159 procedure kits containing sterile water and saline bottles due to leaks at the peel-foil seal interface. The defect could compromise product sterility.
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 FDA Class II recall involves sterile medical device kits with a manufacturing defect in the containment seal. The defect creates a risk-of-harm scenario where the integrity of the sterile product is compromised, with potential for infection if contaminated solutions are used in medical procedures, though no injuries have been reported to date.
Plain-English summary
Medline Industries, LP is recalling 159 procedure kits (REF DYNJ902002J) containing Medline Sterile Water and Medline Sterile 0.9% Normal Saline bottles. The bottles were identified as leaking at the interface where the peel-foil seal meets the bottle opening, which compromises the sterile environment of the solutions inside.
These kits were distributed worldwide, including throughout the United States, Panama, and Canada. The affected lot numbers are 24ABC106, 23KBN892, and 23JBV265.
A compromised seal on sterile solution bottles creates a risk that environmental contamination could enter the container. If contaminated sterile solutions are subsequently used in medical procedures, patients could be exposed to infection. Healthcare providers and patients with these kits should discontinue use immediately and contact Medline Industries regarding returns or replacements.
The recalled product
- Product
- Medline procedure kits, labeled as: HAND, REF DYNJ902002J
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Category
- Medical Device
- Hazard
- product-defect
- 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)
- UDI/DI 10195327516079 (EA) 40195327516070 (CS)
- Lot Numbers: 24ABC106
- 23KBN892
- 23JBV265
Distribution
Distributed nationwide across the United States.
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