FDA Medical Device Recalls (openFDA)
Braun,B Medical Inc: 18G Catheter is a component in various kits.
- Recall number
- Z-1133-04
- Recalling firm
- Braun,B Medical Inc
- Product
- 18G Catheter is a component in various kits.
- Status
- Terminated
- Initiated
- 2004-04-16
- Posted
- 2004-07-22
- Terminated
- 2004-09-14
- Reason
- Catheter separated from the hub.
- Root cause
- Other
- Action
- The recalling firm issued a recall notification letter on March 19, 2004 to their direct accounts. The letter identified the problem and instructs the direct account to destroy individual units but return unopened cases to the recalling firm.
- Quantity
- 1176 units
- Distribution
- The units were sent to medical facilities in the following states, as listed: CA, CO, DC, FL, GA, IL, LA, MA, MI, MD, MN, MO, MS, NC, NJ, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, WI, WV The product was also distributed to the following foreign accounts located in Germany, Japan, Puerto Rico, and South America.
- Lot, serial or model codes
- Catalog/Lot numbers, respectively: 331411/60463283; 331412/60463404; 331417/60440555; 331542/60437004; 331545/60460702; 331565/60468520; 331565/60481188; 331567/60451432; 331567/60481276; 331582/60433989; 331583/60437935; 331585/60454731; 331585/60477325; 331587/60440553; 331592/60454732; 331595/60460707; 331712/60460705; 331812/60444733; 331918/60454742; 331935/60430137; 58003/60447789 ; 580099/60452854; 580125/60480896; 58017660456867 ; 580179/60453991; 580187/60444305; 7B3013/60459863; 7B3040/60451968; S1200600N/60425597; S1200600N/60451313 S1200600N/60435666; S1200600N/60451450
- 510(k) numbers
- ["K961745","K971085"]
- PMA numbers
- not on file
- Product code
- LJS
- 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