Z-2191-2015Class II

American Catheter / Cholangiogram Catheter 9100 Series

Name: Z-2191-2015 American Catheter / Cholangiogram Catheter 9100 Series
Creator: American Catheter Corp
Published: 2015-03-17
License: https://open.fda.gov/license/

American Catheter Corp / initiated 2015-03-17 / Terminated / root cause: manufacturing process

FDA source

American Catheter Corp began a recall of American Catheter / Cholangiogram Catheter 9100 Series on 2015-03-17. FDA classified it as Class II and gives the reason as "Catheters were not sealed before sterilization. and was not detected through subsequent acceptance activities, product release and distribution". 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-2191-2015
Classification: Class II
Status: Terminated
Initiated: 2015-03-17
Posted: 2015-07-22
Terminated: 2016-12-14
Recalling firm: American Catheter Corp
Product: American Catheter / Cholangiogram Catheter 9100 Series.
Product code: GBZ Catheter, Cholangiography
Reason for recall: Catheters were not sealed before sterilization. and was not detected through subsequent acceptance activities, product release and distribution.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Consignees were contacted by telephone of the affected lot number and sent a Recall Script dated 3/17/2015 giving instructions how to respond to this recall.
Quantity in commerce: 890 devices.
Distribution: Distributed in the states of AL, AK, CA, CO, FL, GA, HI, IL, KS, LA, MI, MO, MT, NJ, OH, OK, SC, TN, TX, WA, and WI.
Product codes and lots: Product Number is 9100, Lot # 14101601.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2191-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2191-2015	Class II	Terminated	Voluntary: Firm initiated	2015-07-29	2015-07-22

Product code GBZ

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