Z-3030-2017Class II

VersaSafe Plastic Cannula - 11 Gauge, Model 9391-0200

Name: Z-3030-2017 VersaSafe Plastic Cannula - 11 Gauge, Model 9391-0200
Creator: CareFusion 303, Inc.
Published: 2017-06-30
License: https://open.fda.gov/license/

CareFusion 303, Inc / initiated 2017-06-30 / Terminated / root cause: packaging

FDA source

CareFusion 303, Inc. began a recall of VersaSafe Plastic Cannula - 11 Gauge, Model 9391-0200 Product Usage: Used with secondary IV sets or syringes with a female luer lock adapter to administer... on 2017-06-30. FDA classified it as Class II and gives the reason as "Punctures in blister packaging that was detected during the packaging process". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-3030-2017
Classification: Class II
Status: Terminated
Initiated: 2017-06-30
Posted: 2017-08-11
Terminated: 2021-02-03
Recalling firm: CareFusion 303, Inc
Product: VersaSafe Plastic Cannula - 11 Gauge, Model 9391-0200 Product Usage: Used with secondary IV sets or syringes with a female luer lock adapter to administer fluid and medications through a needle or catheter inserted into a patients artery or vein.
Product code: FPA Set, Administration, Intravascular
Reason for recall: Punctures in blister packaging that was detected during the packaging process.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: BD sent an Urgent Medical Device Recall letter dated June 2017 to affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to discontinue use and return the affected lot to CareFusion for replacement. For recall related questions contact BD Support Center 1-888-562-6018.
Quantity in commerce: 1,546,800 units
Distribution: Worldwide Distribution in the states of : CO, IL, IN, MD, MI, NY, OH, & TX. and foreign countries of: Australia, New Zealand, & Japan.
Product codes and lots: Lot No. 1470303001, 1570314802, 1470303002, 1570317701, 1470304601, 1570317702, 1470306602, 1570317703, 1470306301, 1570317704, 1470306602, 1570322001, 1470311301, 1660771501, 1470306301, 1470311302, 1470314801

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-3030-2017
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-3030-2017	Class II	Terminated	Voluntary: Firm initiated	2017-08-23	2017-08-11

Product code FPA

K945070Class IIVersasae Plastic Cannula- 11 GaugeImed Corp. / cleared 1995-01-13

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)