18G Catheter is a component in various kits.
- Company
- Braun, B Medical Inc
- Recall Initiated
- April 16, 2004
- Posted
- July 22, 2004
- Terminated
- September 14, 2004
- Recall Number
- Z-1133-04
- Quantity
- 1176 units
- Firm Location
- Allentown, PA
Reason for Recall
Catheter separated from the hub.
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 / Code Info
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
Root Cause
Other
Action Taken
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.