Angiotech Recalls Bone Marrow Biopsy Needles Due to Sterile Seal Defect
Angiotech is recalling specific lots of bone marrow biopsy needles because a manufacturing issue may have compromised the sterile seal on the 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 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: The recall involves a medical device where a sterile seal defect poses a risk of infection or harm, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Angiotech (Manan Medical Products, Inc.) is recalling 9,900 units of "J" Type Bone Marrow Needles (11ga x 10 cm) used for manual bone marrow biopsy and aspiration. The recall affects specific model numbers IMKBMN-11R-10-X and IMKBMN-11R-10, with lot numbers LJUE, LEAC, LFKX, LK0J, and LEHU.
The recall was initiated because the company identified an internal manufacturing issue regarding the formation of the sterile seal on some of the blister trays for this product line. This defect could potentially compromise the sterility of the needles.
The affected products were distributed worldwide, including nationwide in the United States (specifically New Jersey) and in Mexico and South Korea. Healthcare facilities and users should stop using the affected lots and contact the recalling firm for instructions on return or replacement.
The recalled product
- Product
- "J" Type Bone Marrow Needle 11ga x 10 cm - Product Usage: Manual surgical instruments for Bone Marrow Biopsy and Aspiration.
- Manufacturer
- Angiotech (Manan Medical Products, Inc.)
- Affected units
- 9,900
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 (7)
- Model Number IMKBMN-11R-10-X
- Lot Numbers LJUE
- LEAC
- LFKX
- Model Number IMKBMN-11R-10
- Lot Numbers LK0J
- LEHU
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
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- ModerateBone Marrow Biopsy Needle Recall Due to Sterile Seal Manufacturing Issue
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- HighBone Marrow Biopsy Needle Recall Due to Sterile Seal Manufacturing Issue
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- ModerateBone Marrow Biopsy Needle Recall Due to Sterile Seal Manufacturing Issue
FDA (Devices) · 2019-02-13
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