FDA Medical Device Recalls (openFDA)
American Catheter Corp: American Catheter / Cholangiogram Catheter 9100 Series.
- Recall number
- Z-2191-2015
- Recalling firm
- American Catheter Corp
- Product
- American Catheter / Cholangiogram Catheter 9100 Series.
- Status
- Terminated
- Initiated
- 2015-03-17
- Posted
- 2015-07-22
- Terminated
- 2016-12-14
- Reason
- Catheters were not sealed before sterilization. and was not detected through subsequent acceptance activities, product release and distribution.
- 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
- 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.
- Lot, serial or model codes
- Product Number is 9100, Lot # 14101601.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- GBZ
- Firm FEI
- 1000151187
- Firm city
- Ocala
- Firm state
- FL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28