HydroMARK Breast Biopsy Marker Label Mismatch on Patient Documentation
Devicor Medical Products is recalling 90 HydroMARK Breast Biopsy Markers due to mismatched patient labels that incorrectly identify the product model. The small patient label identifies the device as model 4010-05-08-T3, while the correct model is 4010-05-08-T4.
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 FDA recall involving a labeling discrepancy on a medical device where incorrect model identification could create confusion in clinical settings. No illnesses or injuries have been reported, placing this within the 'risk-of-harm products where injury has not yet been reported' category per the severity rubric.
Plain-English summary
Devicor Medical Products Inc is recalling 90 HydroMARK Breast Biopsy Markers (Model No. 4010-05-08-T4) due to a labeling mismatch. The primary device label correctly identifies the product as model 4010-05-08-T4, while the smaller patient label provided with the device incorrectly identifies it as model 4010-05-08-T3.
The affected devices have UDI-DI 00841911102472 and Lot F12201281D. They were distributed nationwide across Delaware, Kentucky, New York, Ohio, and West Virginia.
Label mismatches on medical devices can create confusion about product identity. Healthcare providers and patients with these devices should verify the correct model number using the primary device label to ensure proper device identification.
The recalled product
- Product
- HydroMARK Breast Biopsy Marker, Model No. 4010-05-08-T4
- Manufacturer
- Devicor Medical Products Inc
- Hazard
- mislabeling
- model-identification
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 (1)
- UDI-DI: 00841911102472 Lot F12201281D
Distribution
Distributed nationwide across the United States.
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