Class 2 Device Recall

• Date Initiated by Firm: May 27, 2005
• Date Posted: August 03, 2005
• Recall Status: Terminated on January 03, 2007
• Recall Number: Z-1062-05
• Recall Event ID: 32210
• 510(K)Number: K871153 K964929 K970926 K871152 K894446
• Product Classification: Introducer, Catheter - Product Code DYB
• Product: Locking Tear-Away Sheath Introducer Product Line. ; ; ACCUGUIDE SINGLE LUMEN 4FR PICC P460K 5/;; P560K PICC 5FR W/INTRO KIT;; MTI451845 4.5FR MINI T/A;; MTI551845 5.5FR MINI TA;; MTI651845 6.5FR MINI T/A;; P460OTW SNGL LUM PICC W/MTI;; P4552K DBL LUM PICC INTRO KIT;; P5552K DBL LUM PICC INTRO KIT;; P4552KOTW DBL LUM OTW PICC INTRO KIT LF;; LOCKING T/A INTRODUCERS 11FR;; INTRADYN TEAR-AWAY INTRODUCER 4F;; INTRADYN TEAR-AWAY INTRODUCER 5F;; INTRADYN TEAR-AWAY INTRODUCER 6F;; INTRADYN TEAR-AWAY INTRODUCER 7F;; INTRADYN TEAR-AWAY INTRODUCER 8F;; INTRADYN TEAR-AWAY INTRODUCER 9F;; INTRADYN TEAR-AWAY INTRODUCER 10F;; INTRADYN TEAR-AWAY INTRODUCER 11F;; INTRADYN TEAR-AWAY INTRODUCER 12F;; INTRADYN TEAR-AWAY INTRODUCER 15F;; INTRADYN TEAR-AWAY INTRODUCER 16F;; 23HI120 12F X 23CM HEMO INTRO;; 23HI130 13F X 23CM HEMO INTRO;; 30STA8 8FR X30CM T/A INTRO -NJ*;; 30STA9 9FR X 30CM SHEATH -NJ*;; 30STA10 10FR X 30CM T/A INTRO -NJ*;; 30STA12 12FR X 30CM T/A INTRO -NJ*;; 30STA16 16FR X 30CM SHEATH;; BOSTON SCI 16F X 9.54 STEP DIL/SHEATH;; 45STA9 45CM T/A INTRODUCER -NJ*;; LUTHER 6F - T/A ASSM CLIP;; 10HI14038 14F X 11CM HEMO W/WI;; BOSTON SCI 12FX 21.35 DIL/SHEATH;; 10HI12038 12F X 11CM HEMO W/WI;; 10HI13038 13F X 11CM HEMO W/WI;; BOSTON SCI 9F X 9.54 STEP DIL/SH;; BOSTON SCI 9F X 15.44 STEP DIL/SH;; BOSTON SCI 9F X 21.35 STEP DIL/SH;; BOSTON SCI 11F X 9.54 STEP DIL/SH;; BOSTON SCI 11F X 15.44 STEP DIL/SH;; BOSTON SCI 12F X 9.54 DIL/SHEATH;; BOSTON SCI 12F X 15.44 DIL/SHEATH;; BOSTON SCI 14F X 9.54 DIL/SHEATH;; BOSTON SCI 14F X 15.44 DIL/SHEATH;; BOSTON SCI 16F X15.44 DIL/SHEATH;; 30STA15 15FR LONG TA INTRODUCR;; 30STA11 11FR LONG TA INTRODUCR -NJ*;; CARDIAC PACEMAKER T/A SHEATH;; 14FR TA DILATOR/SHEATH-BULK;; 12FR INTRODUCER TEAR AWAY BNS;; 12FR TA DIL/SHEATH LC;; 8FR TA SHEATH;; 10FR TA SHEATH;; 16FR TA SHEATH;; 8/10FR LOCK T/A INTRO STEPPED;; 6FR T/A DILATOR/SHEATH;; 6FR LOCKING T/A INTRO ASSY;; 14FR X 143MM LOCKING T/A INTRODUCERS;; PTFE 4.5 FR BARD ACCESS INTRODUCERS;; PTFE 6.0 FR BARD ACCESS INTRODUCERS;; 7F LOCKING INTRO SYSTEM;; 8 (O/S) FR. LOCKING TEARAWAY INTRODUCER;; 9 FR (0/S) LOCKING INTRO SYSTEM;; 12F LOCKING INTRO SYSTEM;; 14FR LOCKING T/A INTRODUCER;; 10FR X 18 CM LOCKING T/A INTRODUCER;; 14FR X 12MM LOCKING T/A INTRODUCER;; 10.5FR X 18CM LOCKING T/A INTRODUCER;; 10FR X 23CM LOCKING T/A INTRODUCER;; 10FR LOCKING TEAR-AWAY INTRODUCERS;; INTRADYN TEAR-AWAY INTRODUCER 10.5F;; 30STA14 14FR X 30CM T/A INTRO -NJ*;; BOSTON SCIENTIFIC 15FR LOCKING TEARAWAY;; CELSA 5FR LOCKING T/A INTRODUCER;; CORDIS 4'' BLUNT TIP T/A SHEATH;; MEDTRONIC PS MED INTRO ASM 14F -NJ*;; MEDTRONIC PS MED INTRO ASM 15F.
• Code Information: Catalog #, Lot Numbers: 333603--Lot #s 0060529076,0060542787, 0060551433, 0060552115, 0060553837, 0060562411, 0060702019, 0060702049. 333604--0060553838, 0060708443, 0060713806. 333606--0060472888, 0060516047, 0060583876, 0060710305, 0060710306, 0060751880. 333608--0060569225, 0060703806, 0060729030, 3360734585. 333609--0060703808. 333610--0060738852. 333612--0060542791, 0060549251, 0060553963, 0060702064, 0060708037. 333613--0060549252, 0060553909, 0060702069, 0060702071, 0060702074. 333614--0060521374, 0060551766, 0060702082. 610064--0060709374. 610100--0060702177, 0060761533. 610101--0060702179. 610102--0060710159. 610103--0060713850. 610104--0060734898, 0060741005. 610105--0060722688, 0060740847. 610106--0060702186. 610108--0060702192. 610109--0060713856. 610112--0060719604. 610113--0060723081. 610145--0060570243. 610146--0060560608. 610150--0060551068. 610151--0060707659, 0060710792. 610152--0060710794. 610153--0060551073, 0060568835. 610155--0060708367, 0060708367, 0060742089. 610177--0060558435, 0060707652, 0060709662, 0060746191, 0060766191. 610264--0060707534. 610407--0060732173. 610559--0060523821, 0060555811, 0060572434, 0060709663, 0060726953, 0060733425. 610570--0060726955. 610652--0060707368, 0060737064. 610654--006545559, 0060552179, 0060744541. 610811--0060473107, 0060473108, 0060560316, 0060738144. 610812--0060726992. 610813--0060757144. 610814--0060572400, 0060732297. 610815--0060538361, 0060542288, 0060757084. 610816--0060520549, 0060523748, 0060538364, 0060572403, 0060710820, 0060722731. 610817--0060544240, 0060545503, 0060569903, 0060571978. 610818--0060528048, 0060561924, 0060709739, 0060726994. 610819--0060545504, 0060709740, 0060727002. 610820--0060707651. 610830--0060712212, 0060742386. 610843--0060709735. 610894--0060544824, 0060545508, 0060557624, 0060707071, 0060715230, 0060728009, 0060752044, 0060752045. 610916--0060710874, 0060710875. 610923--0060497968, 0060545511, 0060754189, 0060516182, 0060545512, 0060569910. 610974--0060719256. 610976--0060517487, 0060551012, 0060564301, 0060571977, 0060709065, 0060719972. 610982--0060725523. 611109--0060523767, 0060545524, 0060551019, 0060555703, 0060706362, 0060707365, 0060709725, 0060716210. 611172--0060706038. 611840--0060519177, 0060540542, 0060545484, 0060552193, 0060564379, 0060707285, 0060711192, 0060722451. 612001--0060528366, 0060541715, 0060709669. 612122--0060752209. 612124--0060755565, 0060759158. 614006--0060545527, 0060545529, 0060548273, 0060555801, 0060564933, 0060569911, 0060572409, 0060706138, 0060706158, 0060706169, 0060706174, 0060709679, 0060749179. 614007--0060473083, 0060494998, 0060503536, 0060507452, 0060517491, 0060545530, 0060545531, 0060551054, 0060564304, 0060564934, 0060566303, 0060566304, 0060566305, 0060712277, 0060720315, 0060724332, 0060726782, 0060750181. 614008--0060545533, 0060548274, 0060554892, 0060555802, 0060564936, 0060568832, 0060569912, 0060572414, 0060576479, 0060576483, 0060576484, 0060712278, 0060712279, 0060712280, 0060737734. 614012--0060747064. 614037--0060547187, 0060735870. 614100--0060709646, 0060709647, 0060715276, 0060720258, 0060521185, 0060536288, 0060538205, 0060551057, 0060560474, 0060572417. 614101--0060709664, 0060709667, 0060715113. 614102--0060562423, 0060710927. 614104--0060580188, 0060707545. 614400--0060588319, 0060707536, 0060707537, 0060707538, 0060712281, 0060722450, 00607727033, 0060749069. 610107A--0060702191, 0060746124. 610154A--0060709726. 7B2807--0060709702, 0060709703, 0060709704, 0060709705, 0060709709, 0060709710, 0060709711, 0060709719, 0060749170. 7C2100--0060707500, 0060707501, 0060709659. 7C6311--0060482936, 0060489182, 0060496750, 0060505790, 0060506316, 0060523417, 006055541633, 0060543824, 0060543825, 0060543826, 0060548258, 0060555712, 0060557290, 0060561310, 0060578814, 0060710970, 0060720149, 0060726624. 7M3882--0060551059, 0060572130, 0060710976, 0060738147, 0060746766. 7M3883--0060707663, 0060725281.
• Recalling Firm/ Manufacturer: B. Braun Medical, Inc.; 901 Marcon Blvd; Suite 200; Allentown PA 18109-9512
• For Additional Information Contact: Lori Sands; 856-751-2080
• Manufacturer Reason for Recall: Reports that the tearaway introducer sheaths have cracked hubs/handles and/or improper peeling of the sheath during use.
• FDA Determined Cause: Other
• Action: Recall letters shere sent out to the firm''s customers on 5/27/2005 via US Mail, Return Receipt Requested.
• Quantity in Commerce: 11057 cases
• Distribution: The firm distributed the product to 235 customers both US and International. The international customers are located in Germany, Canada, India, Japan, France, Venezuela, Ireland, and Chile.
• Total Product Life Cycle: TPLC 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) Database: 510(K)s with Product Code = DYB and Original Applicant = ANGEION CORP.; 510(K)s with Product Code = DYB and Original Applicant = B. BRAUN MEDICAL, INC.; 510(K)s with Product Code = DYB and Original Applicant = SIGMA DIAGNOSTICS, INC.