Medline Sterile PVP Solution Recalled Due to Non-Sterile Contents
Medline Industries is recalling 8,250 units of sterile PVP solution distributed nationwide because the contents are non-sterile despite being labeled as sterile.
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 of a medical device solution with a documented sterility failure. Although no illnesses or injuries have been reported, non-sterile contents in a product labeled and intended to be sterile presents a risk of harm if the product is used as intended.
Plain-English summary
Medline Industries, LP is recalling 8,250 units of STERILE PVP SOLUTION, REF DYNDA1907 (UDI 40889942574491 case / 10889942574490 each). The affected lot numbers are 22LBL675, 22JBR599, 22IBS045, 22GBT655, 22DBN398, 22DBD250, 22DBA001, 21LBN032, 21JBA478, and 21EBE405. Units were distributed nationwide to healthcare facilities in Connecticut, Iowa, Louisiana, Massachusetts, Pennsylvania, California, New York, and Florida.
The reason for the recall is a mismatch between labeling and product contents. The product labeling states the solution is "Sterile" or "STRL," but the contents inside the foil sachets are non-sterile. This is an FDA Class II recall.
Healthcare facilities that received this product should verify whether they have any affected lot numbers. The U.S. Food and Drug Administration is overseeing this recall.
The recalled product
- Product
- STERILE PVP SOLUTION, REF DYNDA1907
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Affected units
- 8,250
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 (12)
- UDI/DI 40889942574491 (case)
- 10889942574490 (each)
- Lot numbers: 22LBL675
- 22JBR599
- 22IBS045
- 22GBT655
- 22DBN398
- 22DBD250
- 22DBA001
- 21LBN032
- 21JBA478
- 21EBE405
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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