Z-2072-2020Class II

Kiwi Complete Vacuum Delivery System, Model No. VAC-6000MTE -

Name: Z-2072-2020 Kiwi Complete Vacuum Delivery System, Model No. VAC-6000MTE -
Creator: Clinical Innovations, LLC
Published: 2019-08-06
License: https://open.fda.gov/license/

Clinical Innovations, LLC / initiated 2019-08-06 / Terminated / root cause: manufacturing process

FDA source

Clinical Innovations, LLC began a recall of Kiwi Complete Vacuum Delivery System, Model No. VAC-6000MTE - Product Usage: The Kiwi is a disposable vacuum-assisted fetal delivery system on 2019-08-06. FDA classified it as Class II and gives the reason as "There is a potential for loss of vacuum or failure to generate vacuum when using the firm's fetal vacuum delivery system". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2072-2020
Classification: Class II
Status: Terminated
Initiated: 2019-08-06
Posted: 2020-05-21
Terminated: 2022-09-16
Recalling firm: Clinical Innovations, LLC
Product: Kiwi Complete Vacuum Delivery System, Model No. VAC-6000MTE - Product Usage: The Kiwi is a disposable vacuum-assisted fetal delivery system.
Product code: HDB Extractor, Vacuum, Fetal
Reason for recall: There is a potential for loss of vacuum or failure to generate vacuum when using the firm's fetal vacuum delivery system.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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.
Quantity in commerce: 2340 Units
Distribution: OUS customers only.
Product codes and lots: Model No. VAC-6000MTE, lot no. 181144; UDI: 00814247020659

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2072-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2072-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-27	2020-05-21

Product code HDB

K981260Class IIKiwi Soft Cup with Palm Pump Model Number Vfe-6000S, Kiwi Mushroom Cup with Palm Pump Model Vfe-6000MClinical Innovations, Inc. / cleared 1998-09-22

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)