Bone Marrow Biopsy Needle Recall Due to Sterile Seal Manufacturing Issue
Angiotech is recalling 1,404 Bone Marrow Biopsy Needles due to a manufacturing defect in the sterile seal on blister trays.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any hospitalizations, injuries, or illnesses. The hazard is a potential loss of sterility due to a manufacturing defect, which fits the criteria for a moderate risk where harm has not yet been reported.
Plain-English summary
Angiotech (Manan Medical Products, Inc.) is recalling 1,404 units of the Bone Marrow Biopsy Needle (Model UCIN-16-5, Lot LK2L). The recall was initiated because the company identified an internal manufacturing issue affecting the formation of the sterile seal on some of the blister trays used for this product line.
The affected products were distributed worldwide, including nationwide in the United States (specifically New Jersey) and in Mexico and South Korea. These manual surgical instruments are used for bone marrow biopsy and aspiration.
Healthcare facilities and consumers should stop using the affected needles and contact the recalling firm for instructions on return or replacement. The source text does not report any illnesses or injuries associated with this recall.
The recalled product
- Product
- Aguja de Aspiracion con Profundidad Ajustable Tipo I 16ga x 5 cm- Product Usage: Manual surgical instruments for Bone Marrow Biopsy and Aspiration.
- Manufacturer
- Angiotech (Manan Medical Products, Inc.)
- Affected units
- 1,404
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 (2)
- Model Number UCIN-16-5
- Lot Number LK2L
Distribution
Part of a larger recall action
This product is one of 7 recalled by Angiotech (Manan Medical Products, Inc.) 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.
See all 7 products in this recall →Related recalls
Same manufacturer · Angiotech (Manan Medical Products, Inc.)
See all →- HighAngiotech Recalls Bone Marrow Needles Due to Sterile Seal Manufacturing Issue
FDA (Devices) · 2019-02-13
- HighBone Marrow Biopsy Needle Recall Due to Sterile Seal Manufacturing Issue
FDA (Devices) · 2019-02-13
- ModerateBone Marrow Biopsy Needle Recall Due to Sterile Seal Manufacturing Issue
FDA (Devices) · 2019-02-13
- HighBone Marrow Biopsy Needle Recall Due to Sterile Seal Manufacturing Issue
FDA (Devices) · 2019-02-13
- HighAngiotech Recalls Bone Marrow Biopsy Needles Due to Sterile Seal Defect
FDA (Devices) · 2019-02-13
Same hazard · sterility compromise
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