| | Class 2 Device Recall Kiwi Omni Vacuum Delivery System |  |
| Date Initiated by Firm | March 09, 2026 |
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| Date Posted | April 24, 2026 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-1945-2026 |
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| Recall Event ID |
98597 |
| 510(K)Number | K981260 |
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| Product Classification |
Extractor, vacuum, fetal - Product Code HDB
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| Product | Brand Name: Kiwi Omni Vacuum Delivery System
Product Name: Kiwi Omni Vacuum Delivery System
Model/Catalog Number: VAC-6000MT
Product Description: The Clinical Innovations Kiwi is a disposable vacuum assisted fetal delivery system. It is
a sterile, single-patient-use device designed to provide assistance in childbirth under the
following conditions: 1) Term pregnancy, 2) Ruptured amniotic membranes, 3) Engaged head,
4) Complete cervical dilation, and 5) Adequately trained or supervised operator. |
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| Code Information |
Model/Catalog Number: VAC-6000MT
UDI: 00814247020642
Lot Code:
251327
251333
251328
251330
251370
251388
251545
251546
251582
251583
251680
251681 |
| FEI Number |
1000220650
|
Recalling Firm/
Manufacturer |
Clinical Innovations, LLC
747 W 4170 S
Murray UT 84123-1364
|
| For Additional Information Contact | Nicole Boser
801-268-8200 |
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Manufacturer Reason
for Recall | Due to complaints of device breakage at the traction force gauge to handle joint. |
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FDA Determined
Cause 2 | Under Investigation by firm |
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| Action | On 03/10/2026, the firm emailed an "URGENT MEDICAL DEVICE RECALL" Letter to customers informing them that there is a potential of failure on the handle breaking at the Traction Force Indicator handle joint on the Kiwi Complete Vacuum Delivery System (VAC-6000MT) when angular force is applied to the handle.
Customers are instructed to:
1. Identify and quarantine all unused inventory of the affected product.
2. Discontinue distribution of the affected product.
3. Return all unused, affected product to Clinical Innovations (Laborie), regardless of the labeled expiration date.
4. Complete and return the attached Recall Acknowledgement and Receipt Form within 15 business days, even if no inventory remains. Return the forms via email to recalls@Laborie.com.
5. If customers have product to return, a company representative will contact them once Clinical Innovations has receive their Recall Acknowledgement and Receipt Form to issue them an RMA per company policy and arrange for a product return.
For questions, call Clinical Innovations (Laborie), at 1-(888)- 268-6222 M-F 8:00 AM- 5:00 PM MT or + (33) 383 22 20 76 M-F 8:00 AM - 5 PM GMT +2 or their Clinical Innovation's (Laborie) service representative. |
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| Quantity in Commerce | 49,175 devices |
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| Distribution | Worldwide - U.S. Nationwide distribution including in the states of AK, AR, AZ, CA, CO, CT, DC, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, MI, MI, MN, MS, NC, NE, NH, NV, NY, OH, PR, SD, TN, TX, UT, VA, WA, WI, WV, and WY. The countries of Canada, China, Japan, Czech Republic, and Singapore.
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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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database | 510(K)s with Product Code = HDB
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