M-Close Kit suturing apparatus recalled due to plastic housing fracture risk
New Wave Endo-Surgical is recalling the M-Close Kit surgical suturing apparatus because the plastic housing may fracture. The recall affects 295 units distributed in Florida, Massachusetts, and Georgia.
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: This is an FDA Class II recall of a medical device with potential for functional failure (plastic housing fracture) but no reported illnesses or injuries. The hazard presents a risk-of-harm to patients during surgical use but has not yet resulted in reported adverse events.
Plain-English summary
New Wave Endo-Surgical, Corp. is recalling the M-Close Kit, REF 27-101, a disposable surgical apparatus designed for ligature passing and suturing of the abdominal wall. The device serves as a needle guide in surgical procedures.
The plastic housing on the M-Close Kit may fracture during use. Device fracture could impair the kit's intended function and potentially affect patient safety during surgical procedures.
The recall affects 295 units distributed nationwide in Florida, Massachusetts, and Georgia. The affected lot code is C2020 (UDI/DI: 00850009417022).
Patients and healthcare providers should contact New Wave Endo-Surgical, Corp. for recall information and instructions on returning or replacing affected units. Healthcare facilities should verify whether they have the recalled product and take appropriate action to prevent use of affected devices.
The recalled product
- Product
- M-Close Kit, REF 27-101; a disposable, ligature passing, suturing apparatus and needle guide for the abdominal wall
- Manufacturer
- New Wave Endo-Surgical, Corp.
- Hazard
- Affected units
- 295
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)
- UDI/DI: 00850009417022
- Lot code C2020
Distribution
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