Sterile PVP Solution Kit Recalled for Non-Sterile Contents
Medline STERILE PVP SLN KIT (Lot 21GBJ087) is recalled because its contents are non-sterile despite labeling stating sterile product. Consumers should stop use immediately.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 an FDA Class II recall involving a non-sterile product labeled as sterile. It represents a risk-of-harm product in contexts where sterilization is critical, though no illnesses or injuries have been reported. The hazard falls under the rubric criterion for Score 3.
Plain-English summary
Medline Industries, LP is recalling the STERILE PVP SLN KIT (REF DYNDM1097, Lot 21GBJ087) due to a critical labeling-content discrepancy. The product's external labeling indicates the contents are sterile; however, the solution inside the foil sachet is non-sterile.
This mismatch presents a patient safety risk. The product is intended for use in medical settings where sterilized materials are required. Use of non-sterile solution in procedures requiring sterile conditions could result in contamination and potential infection.
The recalled product was distributed nationwide to healthcare facilities in Connecticut, Iowa, Louisiana, Massachusetts, Pennsylvania, California, New York, and Florida. Approximately 100 units with Lot 21GBJ087 are affected.
Consumers and healthcare providers should immediately stop using this product. Contact Medline Industries, LP for instructions on safe return or disposal of affected units.
The recalled product
- Product
- STERILE PVP SLN KIT, REF DYNDM1097
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 100
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 (3)
- UDI/DI 40884389601892 (case)
- 10884389601891 (each)
- Lot numbers: 21GBJ087
Distribution
Part of a larger recall action
This product is one of 7 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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