Soft Tissue Biopsy Needles Recalled for Potential Sterility Compromise
M.D.L. S.r.l. has recalled approximately 20,129 soft tissue biopsy needles nationwide because sterility assurance may be compromised.
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 an FDA Class II medical device recall for biopsy needles with potential sterility compromise. No illnesses or injuries have been reported, but compromised sterility on invasive medical devices poses a significant risk of infection.
Plain-English summary
M.D.L. S.r.l. is recalling soft tissue biopsy needles nationwide due to potential compromise of sterility assurance. The recall affects approximately 20,129 units across multiple models distributed to healthcare facilities.
The recall includes numerous models in the MGK, PD, PD0PP, and TY series with specific lot numbers. Complete information on all affected models and lot numbers is available from the FDA and the manufacturer.
Healthcare facilities and practitioners should identify any affected needles in inventory by matching against the specific model and lot numbers. Do not use recalled devices for patient procedures. Contact M.D.L. S.r.l. or the FDA for information regarding replacement or proper disposal.
The recalled product
- Product
- Soft Tissue Biopsy Needles
- Manufacturer
- M.D.L. S.r.l.
- Hazard
- sterility-compromise
- infection-risk
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 (20)
- Model MGK11210
- Lot Numbers: 5216C Model MGK11410
- Lot Numbers: 5216C
- 1217B
- 3620D Model MGK11413
- Lot Numbers: 5216C Model MGK11415
- Lot Numbers: 3620D Model MGK11610
- 3620D Model MGK11615
- Lot Numbers: 3620D Model MGK11616
- 1217B Model MGK11620
- Lot Numbers: 1617A Model MGK11810
- Lot Numbers: 5216C Model MGK11816
- Lot Numbers: 5216C Model MGK11820
- 4617 Model MGK11825
- Lot Numbers: 5216C
- 3620D
- 3620E Model PD01415
- Lot Numbers: 3620D
- 3620E Model PD01416
- 1417A Model PD01420
Distribution
Distributed nationwide across the United States.
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