| Date Initiated by Firm | July 08, 2020 |
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| Date Posted | May 09, 2023 |
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| Recall Status1 |
Terminated 3 on July 02, 2024 |
| Recall Number | Z-1570-2023 |
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| Recall Event ID |
92005 |
| Product Classification |
Instrument, ligature passing and knot tying - Product Code HCF
|
| Product | M-Close Kit, REF 27-101; a disposable, ligature passing, suturing apparatus and needle guide for the abdominal wall |
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| Code Information |
UDI/DI: 00850009417022, Lot code C2020 |
Recalling Firm/
Manufacturer |
New Wave Endo-Surgical, Corp.
6601 Lyons Rd Ste D8
Coconut Creek FL 33073-3630
|
| For Additional Information Contact | Theo Dienes
888-700-8890 |
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Manufacturer Reason
for Recall | The plastic housing on the device may fracture |
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FDA Determined
Cause 2 | Under Investigation by firm |
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| Action | New Wave Endo issued an URGENT MEDICAL DEVICE VOLUNTARY RECALL NOTIFICATION to its consignees by email on 07/08/2020. The notice explained the problem with the device and requested the consignee quarantine the device and respond using the recall acknowledgement form. The units were returned and replaced. |
|---|
| Quantity in Commerce | 295 units |
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| Distribution | US Nationwide distribution in the states of FL, MA, and GA. |
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| Total Product Life Cycle | TPLC Device Report |
|---|
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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