American Catheter Corp: Medical Device Recall in 2015 - (Recall #: Z-2191-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

American Catheter / Cholangiogram Catheter 9100 Series.

Product Classification:

Class II

Date Initiated: March 17, 2015

Date Posted: July 29, 2015

Recall Number: Z-2191-2015

Event ID: 71263

Reason for Recall:

Catheters were not sealed before sterilization. and was not detected through subsequent acceptance activities, product release and distribution.

Status: Terminated

Product Quantity: 890 devices.

Code Information:

Product Number is 9100, Lot # 14101601.

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated