FDA Medical Device Recalls (openFDA)
Braun,B Medical Inc: Introcan Safety IV Catheter 22G x 1'' PUR with Wings. The affected catalogs and lot numbers: Catalog Number 4253540 - Lot number 3G26258U02 Catalog Number 4253540 - Lot number 3G27258U02
- Recall number
- Z-1092-04
- Recalling firm
- Braun,B Medical Inc
- Product
- Introcan Safety IV Catheter 22G x 1'' PUR with Wings. The affected catalogs and lot numbers: Catalog Number 4253540 - Lot number 3G26258U02 Catalog Number 4253540 - Lot number 3G27258U02
- Status
- Terminated
- Initiated
- 2004-03-19
- Posted
- 2004-07-20
- Terminated
- 2004-09-21
- Reason
- Mislabeled product. The recalling firm received a complaint that a box of Introcan Safety Catheters, (22G x 1 inch) contained mixed 18G catheters with the same lot number.
- Root cause
- Other
- Action
- The recalling firm received a product complaint of a mixed 18G Catheters with 22G Catheters.
- Quantity
- 86 units
- Distribution
- The affected recalling units were distributed nationwide to the following states: AZ, CA, GA, IL, IN, MD, OH, OK, OR, MA, MI, NC, NJ, NY, OR, PA, TX, UT, VA, WI
- Lot, serial or model codes
- Catalog Number is 4253540 and the lot numbers are 3G26258U02 and 3G27258U02
- 510(k) numbers
- ["K020785","K982805"]
- PMA numbers
- not on file
- Product code
- FOZ
- Firm FEI
- 2523676
- Firm city
- Allentown
- Firm state
- PA
- 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