"J" Type Bone Marrow Needle 11ga x 10 cm - Product recall
"J" Type Bone Marrow Needle 11ga x 10 cm - Product Usage: Manual surgical instruments for Bone Marrow Biopsy and Aspiration.
Why was "J" Type Bone Marrow Needle 11ga x 10 cm - Product recalled?
Argon Medical has identified an internal manufacturing issue on the formation of the sterile seal on some of their blister trays for the Bone Marrow Biopsy Needle tray product line
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Model Number IMKBMN-11R-10-X, Lot Numbers LJUE, LEAC, LFKX; Model Number IMKBMN-11R-10, Lot Numbers LK0J, LEHU
- Product
- "J" Type Bone Marrow Needle 11ga x 10 cm - Product Usage: Manual surgical instruments for Bone Marrow Biopsy and Aspiration.
- Recalling firm
- Angiotech (Manan Medical Products, Inc.)
- Quantity
- 9,900 units
- Distribution
- Worldwide distribution - US Nationwide in the states of New Jersey, and countries of Mexico and South Korea.
- Recall date
- February 13, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)