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U.S. Department of Health and Human Services

Class 2 Device Recall 18G Catheter

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 Class 2 Device Recall 18G Cathetersee related information
Date Initiated by FirmApril 16, 2004
Date PostedJuly 22, 2004
Recall Status1 Terminated 3 on September 14, 2004
Recall NumberZ-1133-04
Recall Event ID 28911
510(K)NumberK961745 K971085 
Product Classification Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days - Product Code LJS
Product18G Catheter is a component in various kits.
Code Information 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
Recalling Firm/
Manufacturer		 Braun,B Medical Inc
901 Marcon Blvd
Allentown PA 18109-9512
For Additional Information ContactArt Morse
610-266-0500
Manufacturer Reason
for Recall		Catheter separated from the hub.
FDA Determined
Cause 2		Other
ActionThe 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 in Commerce1176 units
DistributionThe 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.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = LJS
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