Medline Blood Pressure Units Recalled for Manufacturing Specification Non-Compliance
Medline Industries is recalling 74,339 blood pressure units nationwide (models MDS4001, MDS4001LA, MDS4001PLUS) due to manufacturing non-compliance with specifications.
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 Class II recall involves manufacturing non-compliance with specifications for a medical device. No injuries or illnesses have been reported. This aligns with the rubric criterion for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Medline Industries, LP is recalling 74,339 Blood Pressure Units nationwide, including models MDS4001, MDS4001LA, and MDS4001PLUS. These blood pressure monitors were manufactured non-compliant with the company's specifications.
Although the units did not conform to specifications, Medline's Receiving Department accepted the non-compliant units into inventory.
The recalled product
- Product
- Blood Pressure Unit, Model (REF) Numbers: a) MDS4001, b) MDS4001LA, c) MDS4001PLUS
- Manufacturer
- MEDLINE INDUSTRIES, LP - Northfield
- Hazard
- Affected units
- 74,339
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 (18)
- a) MDS4001
- UDI/DI 100888277361228
- Lot Numbers: 230280001
- 230380001
- 230680001
- 230780001
- 230880001
- b) MDS4001LA
- UDI/DI 100884389106955
- Lot Numbers: 230480003
- 230780003
- 231180003
- c) MDS4001PLUS
- UDI/DI 100888277362089
- Lot Numbers: 230280004
- 230480004
- 230780004
- 231080004
Distribution
Distributed nationwide across the United States.
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