Z-0812-2016Class III

REF 0038460 Toomey Syringe 70cc Syringe with Catheter Tip and Luer Tip Adapters, Single Use, Rx Only, Latex...

Name: Z-0812-2016 REF 0038460 Toomey Syringe 70cc Syringe with Catheter Tip and Luer Tip Adapters, Single Use, Rx Only, Latex...
Creator: C.R. Bard, Inc.
Published: 2016-01-04
License: https://open.fda.gov/license/

C.R. Bard Inc / initiated 2016-01-04 / Terminated / root cause: packaging

FDA source

C.R. Bard, Inc. began a recall of REF 0038460 Toomey Syringe 70cc Syringe with Catheter Tip and Luer Tip Adapters, Single Use, Rx Only, Latex Free, 50 units. Product Usage: Product is intended... on 2016-01-04. FDA classified it as Class III and gives the reason as "Report by a customer of an open package seal". 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-0812-2016
Classification: Class III
Status: Terminated
Initiated: 2016-01-04
Posted: 2016-02-16
Terminated: 2017-06-06
Recalling firm: C.R. Bard Inc
Product: REF 0038460 Toomey Syringe 70cc Syringe with Catheter Tip and Luer Tip Adapters, Single Use, Rx Only, Latex Free, 50 units. Product Usage: Product is intended for Resectoscope irrigation, catheter irrigation and Foley catheter inflation.
Product code: KYZ Syringe, Irrigating (Non Dental)
Reason for recall: Report by a customer of an open package seal.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: BMD sent an Urgent Medical Product Recall letter to each of the customers via FedEx with proof of delivery notice. The leter identified the affected product, problem and actions to be taken. All consignees were instructed to carry out the recall to the user level. The letter included a Recall and Effectiveness Check Form which was to be returned to Bard.
Quantity in commerce: 15,400 units
Distribution: US Nationwide Distribution - in the states of: AL, AZ, CA, CO, FL, GA, IL, IN, IA, KS, KY, LA, MD, MI, MS, MO, NE, NV, NJ, NM, NY, NC, OH, OK, PA, SC, TN, TX, VA, WA, WV, and Puerto Rico
Product codes and lots: Lot Number NGZE1190

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0812-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0812-2016	Class III	Terminated	Voluntary: Firm initiated	2016-02-24	2016-02-16

Product code KYZ

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)