M-Close Kit recall
M-Close Kit, REF 27-101; a disposable, ligature passing, suturing apparatus and needle guide for the abdominal wall
Why was M-Close Kit recalled?
The plastic housing on the device may fracture
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?
UDI/DI: 00850009417022, Lot code C2020
- Product
- M-Close Kit, REF 27-101; a disposable, ligature passing, suturing apparatus and needle guide for the abdominal wall
- Recalling firm
- New Wave Endo-Surgical, Corp.
- Quantity
- 295 units
- Distribution
- US Nationwide distribution in the states of FL, MA, and GA.
- Recall date
- May 17, 2023
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)