Mammary Nodule Localization Devices Recalled for Sterility Assurance Issues
M.D.L. S.r.l. is recalling 320 units of Mammary Nodules Localization devices distributed nationwide due to potential compromise of sterility assurance.
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 medical device recall due to potential compromise of sterility assurance. The hazard is theoretical with no reported illnesses or injuries documented in the source. Per the rubric, Class II recalls without reported hospitalization and with theoretical hazards score at most 3 (High).
Plain-English summary
M.D.L. S.r.l. is recalling 320 units of Mammary Nodules Localization devices distributed nationwide. The recall was initiated due to potential compromise of sterility assurance.
Affected device model numbers include PN2010, PN2012, PN2015, PNA2005, PNA2010, PNA2015, PNAX2005, PNS2010, PNS2015, PNX2010, PR2005, PR2007, PR2010, and PR2015. Specific lot numbers are listed in the FDA recall notice and should be checked to determine if a device in your facility is affected.
Healthcare providers and patients should contact the manufacturer for guidance. Instructions for proper handling, testing, or replacement of affected devices can be obtained from M.D.L. S.r.l. or the FDA.
The recalled product
- Product
- Mammary Nodules Localization
- Manufacturer
- M.D.L. S.r.l.
- Hazard
- Affected units
- 320
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 (16)
- Model Number PN2010
- Lots: 3620D Model Number PN2012
- Lots: 1317 Model Number PN2015
- Lots: 3620D Model Number PNA2005
- Lots: 5216C Model Number PNA2010
- Lots: 3620D Model Number PNA2015
- Lots: 3620D Model Number PNAX2005
- Lots: 5216C Model Number PNS2010
- Lots: 3620D Model Number PNS2015
- Lots: 3620D Model Number PNX2010
- Lots: 0817A Model Number PR2005
- Lots: 5216C
- 4920B Model Number PR2007
- Lots: 5216C Model Number PR2010
- Lots: 3620D Model Number PR2015
- Lots: 3620D
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 5 recalled by M.D.L. S.r.l. 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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