510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
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Z-1062-05

Locking Tear-Away Sheath Introducer Product Line. ACCUGUIDE SINGLE LUMEN 4FR PICC P460K 5/; P560K PICC 5FR...

B Braun Medical Inc / initiated 2005-05-27 / Terminated
FDA source (opens on fda.gov)

B. Braun Medical, Inc. began a recall of 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... on . The reason FDA records is "Reports that the tearaway introducer sheaths have cracked hubs/handles and/or improper peeling of the sheath during use". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-1062-05
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
B Braun Medical Inc
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.
Product code
DYB Introducer, Catheter
Reason for recall
Reports that the tearaway introducer sheaths have cracked hubs/handles and/or improper peeling of the sheath during use.
FDA root 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.
Product codes and lots
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.