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Kiwi OmniCup recallZ-2072-2020 · Clinical Innovations, LLC · initiated Aug 6, 2019

Terminated

Is my device affected?

  1. Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
  2. If yours is listed, follow the instructions from Clinical Innovations, LLC or your healthcare provider. The company's action is summarized under what the company is doing.
  3. Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

There is a potential for loss of vacuum or failure to generate vacuum when using the firm's fetal vacuum delivery system.

FDA root cause category: Process control

What the company is doing

Clinical Innovations sent Field Safety Notice Letters to their distributors via email on July 2, 2019. The letter notified distributors that the firm had received reports of Kiwi devices that fail to generate or maintain vacuum during use. Distributors were informed that Clinical Innovations conducted an investigation on the returned devices and concluded that these are associated with a manufacturing nonconformity caused by not applying enough solvent during the production process. The Field Safety Notice Letters also noted that Clinical Innovations had not received any reports of patient harm associated with Lot 181144. Distributors were requested to provide this information to their hospitals, and, if hospitals had further distributed this product, to, in turn, identify their customers and notify them at once of this communication and/or contact Clinical Innovations with the contact information so that the firm could follow-up with the owner of the device. Customers were instructed to quarantine any remaining product in their hospitals and complete the response card attached to the Field Safety Notice. Customers were informed that a company representative would contact them and arrange for the return of the product. Customers were instructed to contact Clinical Innovations, at +{33) 383 22 20 76 M-F 8:00AM- 5 PM GMT+2 or 1-{888)- 268-6222 M-F 8:00AM-5:00PM MT or their Clinical Innovation's service representative with any questions.

Recall details

Recall number
Z-2072-2020
Status
Terminated
Initiated by the company
Aug 6, 2019
Recalling firm
Clinical Innovations, LLC
Quantity
2340 Units
Product code
HDB
FDA submissions
K981260
Distribution
OUS customers only.

Product description

Kiwi Complete Vacuum Delivery System, Model No. VAC-6000MTE - Product Usage: The Kiwi is a disposable vacuum-assisted fetal delivery system.

Code information (models, lots, serial numbers)

Model No. VAC-6000MTE, lot no. 181144; UDI: 00814247020659

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Product lines

Other devices under the same FDA submission

5 devices cleared under K981260 are not named by identifier in this recall. One submission often covers many models, so they may or may not be affected.

Sources and updates

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