Bone Marrow Biopsy Needle Recall Due to Sterile Seal Manufacturing Issue
Angiotech is recalling 500 units of Double Diamond J Type Bone Marrow 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 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 with a defect in the sterile seal, which poses a risk of infection or harm if used, but the source text does not report any specific injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Angiotech (Manan Medical Products, Inc.) is recalling 500 units of the Double Diamond J Type Bone Marrow Needle & Marrow Extraction Cannula (11ga x 10cm, 14MTWX x 12.5 cm). The recall involves Model Number BMNJ-MEC-1110, Lot Number LHT1.
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 the Bone Marrow Biopsy Needle product line. This defect could potentially compromise the sterility of the medical devices.
The affected products were distributed worldwide, including nationwide in the United States (specifically New Jersey) and in Mexico and South Korea. Healthcare providers and facilities that have received these specific units should stop using them and contact the recalling firm for instructions on return or disposal.
The recalled product
- Product
- Double Diamond J Type Bone Marrow Needle & Marrow Extraction Cannula 11ga x 10cm 14MTWX x 12.5 cm
- Manufacturer
- Angiotech (Manan Medical Products, Inc.)
- Affected units
- 500
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 BMNJ-MEC-1110
- Lot Number LHT1
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
- 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
- ModerateBone Marrow Biopsy Needle Recall Due to Sterile Seal Manufacturing Issue
FDA (Devices) · 2019-02-13
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