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Class 1 Device Recall TB Series Bipolar Pacing Leads |
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| Date Initiated by Firm |
September 26, 2018 |
| Date Posted |
November 08, 2018 |
| Recall Status1 |
Terminated 3 on August 04, 2022 |
| Recall Number |
Z-0391-2019 |
| Recall Event ID |
80984 |
| 510(K)Number |
K884866 K861403
|
| Product Classification |
Electrode, pacemaker, temporary - Product Code LDF
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| Product |
TB Series Bipolar Pacing Leads, French Size 4F, 5F, 6F for Curve Type Straight, Atrial J, 60 degree Curve, and Right Heart. TB is packaged for sterile single use in a double tray. The lead is placed in a PETG inner tray that is sealed with a Tyvek inner lid. The sealed inner tray is placed in an outer PETG tray. The outer tray is sealed with an outer Tyvek lid. An inner label is placed on the outer Tyvek lid. The sealed trays are placed in a labeled white shelf box with on Instruction for use. Packed on lead per outer white shelf box. |
| Code Information |
Item Number (Lot Number): a. TB Lead, 4F Un-Shrouded, Model Number 020004 - 2B-81-532Z-D (OR-03868), 2B-81-532Z-D (OR-03874), 2B-81-532Z-D (C1-06951), 2B-81-532Z-D (C1-06993), 2B-81-532Z-D (C1-06994), 2B-81-532Z-D (C1-07016), 2B-81-532Z-D (C1-07018), 2B-81-532Z-D (C1-07017), 2B-81-532Z-D (D1-02633), 2B-81-532Z-D (D1-02883), 2B-81-532Z-D (DP-01395), 2B-81-532Z-D (OR-04404), 2B-81-532Z-D (C1-09074), 2B-81-532Z-D (C1-09166), 2B-81-532Z-D (DP-02801), 2B-81-532Z-D (DP 02801), 2B-81-532Z-D (DP-04451), 2B-81-532Z-D (DP-05052), 2B-81-532Z-D (DP-05115), 2B-81-532Z-D (DP-05225), 2B-81-532Z-D (DP-05371), 2B-81-532Z-D (DP-05482), 2B-81-532Z-D (DP-05516), 2B-81-532Z-D (DP-05938), 2B-81-532Z-D (DP05968), 2B-81-532Z-D (DP-05976), 2B-81-532Z-D (DP-05998), 2B-81-532Z-D (DP-06062), 2B-81-532Z-D (DP-06098), 2B-81-532Z-D (DP-06203), 2B-81-532Z-D (DP-07789), 2B-81-532Z-D (DP-07840), 2B-81-532Z-D (DP-08130); b. TB LEAD, 5F UN-SHROUDED, Model Number 020005 - 2B-81-532Z-E (D2-01795), 2B-81-532Z-E (C1-06923), 2B-81-532Z-E (C1-06946), 2B-81-532Z-E (C1-06947), 2B-81-532Z-E (C1-06945), 2B-81-532Z-E (C1-06997), 2B-81-532Z-E (C1-06995), 2B-81-532Z-E (C1-06996), 2B-81-532Z-E (C1-07013), 2B-81-532Z-E (C1-07015), 2B-81-532Z-E (C1-07012), 2B-81-532Z-E (C1-07014), 2B-81-532Z-E (D2-01939), 2B-81-532Z-E (D1-02542), 2B-81-532Z-E (D1-02805), 2B-81-532Z-E (DP-01259), 2B-81-532Z-E (DP-01455), 2B-81-532Z-E (DP-01554), 2B-81-532Z-E (OR-04380), 2B-81-532Z-E (C1-08496), 2B-81-532Z-E (C1-08486), 2B-81-532Z-E (C1-08497), 2B-81-532Z-E (C1-08495), 2B-81-532Z-E (OR-04407), 2B-81-532Z-E (C1-08487), 2B-81-532Z-E (C1-08488), 2B-81-532Z-E (C1-08499), 2B-81-532Z-E (C1-08494), 2B-81-532Z-E (C1-08498), 2B-81-532Z-E (C1-08678), 2B-81-532Z-E (C1-08676), 2B-81-532Z-E (C1-08677), 2B-81-532Z-E (C1-08686), 2B-81-532Z-E (C1-08687), 2B-81-532Z-E (C1-08688), 2B-81-532Z-E (C1-08689), 2B-81-532Z-E (C1-08691), 2B-81-532Z-E (C1-08685), 2B-81-532Z-E (C1-08679), 2B-81-532Z-E (C1-08693), 2B-81-532Z-E (C1-08694), 2B-81-532Z-E (DP-02161), 2B-81-532Z-E (C1-08692), 2B-81-532Z-E (C1-09046), 2B-81-532Z-E (C1-09047), 2B-81-532Z-E (C1-09048), 2B-81-532Z-E (C1-09251), 2B-81-532Z-E (C1-09252), 2B-81-532Z-E (C1-09253), 2B-81-532Z-E (DP-02766), 2B-81-532Z-E (DP-02790), 2B-81-532Z-E (DP-02844), 2B-81-532Z-E (DP-03289), 2B-81-532Z-E (DP-03247), 2B-81-532Z-E (DP-03424), 2B-81-532Z-E (DP-04422), 2B-81-532Z-E (DP-04455), 2B-81-532Z-E (DP-04504), 2B-81-532Z-E (DP-04772), 2B-81-532Z-E (DP-04815), 2B-81-532Z-E (DP-04817), 2B-81-532Z-E (DP-04957), 2B-81-532Z-E (DP-05027), 2B-81-532Z-E (DP-05044), 2B-81-532Z-E (DP-05045), 2B-81-532Z-E (DP-05116), 2B-81-532Z-E (DP-05045_1), 2B-81-532Z-E (DP 05116), 2B-81-532Z-E (DP-05274), 2B-81-532Z-E (DP-05417), 2B-81-532Z-E (DP-05543), 2B-81-532Z-E (DP-05686), 2B-81-532Z-E (DP-05687), 2B-81-532Z-E (DP-05958), 2B-81-532Z-E (DP-06080), 2B-81-532Z-E (DP-06060), 2B-81-532Z-E (DP-06141), 2B-81-532Z-E (DP-06206), 2B-81-532Z-E (DP-06346), 2B-81-532Z-E (DP-06535), 2B-81-532Z-E (DP-06762), 2B-81-532Z-E (DP-06568), 2B-81-532Z-E (DP-07015), 2B-81-532Z-E (DP-07018), 2B-81-532Z-E (DP-07017), 2B-81-532Z-E (DP-07146), 2B-81-532Z-E (DP-07262), 2B-81-532Z-E (DP-07438), 2B-81-532Z-E (DP-07500), 2B-81-532Z-E (DP-07642), 2B-81-532Z-E (DP-07787), 2B-81-532Z-E (DP-07643); c. TB LEAD, 6F UN-SHROUDED, 020006 - 2B-81-532Z-F (D2-01775), 2B-81-532Z-F (D2-01691), 2B-81-532Z-F (OR-03853), 2B-81-532Z-F (OR-03961), 2B-81-532Z-F (OR-03878), 2B-81-532Z-F (OR-03939), 2B-81-532Z-F (C1-06953), 2B-81-532Z-F (C1-06954), 2B-81-532Z-F (C1-06955), 2B-81-532Z-F (C1-06956), 2B-81-532Z-F (OR-04060), 2B-81-532Z-F (D1-02562), 2B-81-532Z-F (OR-04100), 2B-81-532Z-F (C1-07081), 2B-81-532Z-F (C1-07082), 2B-81-532Z-F (C1-07079), 2B-81-532Z-F (C1-07080), 2B-81-532Z-F (D1-02806), 2B-81-532Z-F (DP-01003), 2B-81-532Z-F (DP-01004), 2B-81-532Z-F (DP-01214), 2B-81-532Z-F (C1-07955), 2B-81-532Z-F (DP-01082), 2B-81-532Z-F (C1-07945), 2B-81-532Z-F (C1-07946), 2B-81-532Z-F (C1-07958), 2B-81-532Z-F (C1-07964), 2B-81-532Z-F (C1-07956), 2B-81-532Z-F (OR-04278), 2B-81-532Z-F (C1-07966), 2B-81-532Z-F (DP-01569), 2B-81-532Z-F (C1-07957), 2B-81-532Z-F (C1-07959), 2B-81-532Z-F (C1-07960), 2B-81-532Z-F (C1-07961), 2B-81-532Z-F (C1-07962), 2B-81-532Z-F (C1-07963), 2B-81-532Z-F (C1-07965), 2B-81-532Z-F (DP-01374), 2B-81-532Z-F (DP-01492), 2B-81-532Z-F (DP-01553), 2B-81-532Z-F (OR-04329), 2B-81-532Z-F (OR-04330), 2B-81-532Z-F (DP-01601), 2B-81-532Z-F (C1-08396), 2B-81-532Z-F (C1-08407), 2B-81-532Z-F (C1-08410), 2B-81-532Z-F (C1-08409), 2B-81-532Z-F (C1-08411), 2B-81-532Z-F (C1-08412), 2B-81-532Z-F (OR-04367), 2B-81-532Z-F (C1-08398), 2B-81-532Z-F (OR-04408), 2B-81-532Z-F (OR-04369), 2B-81-532Z-F (OR-04399), 2B-81-532Z-F (OR-04368), 2B-81-532Z-F (OR-04366), 2B-81-532Z-F (C1-08670), 2B-81-532Z-F (C1-08666), 2B-81-532Z-F (C1-08667), 2B-81-532Z-F (C1-08668), 2B-81-532Z-F (C1-08669), 2B-81-532Z-F (C1-08674), 2B-81-532Z-F (C1-08675), 2B-81-532Z-F (C1-08704), 2B-81-532Z-F (C1-08705), 2B-81-532Z-F (C1-08706), 2B-81-532Z-F (C1-08711), 2B-81-532Z-F (C1-08718), 2B-81-532Z-F (C1-08720), 2B-81-532Z-F (C1-08709), 2B-81-532Z-F (C1-08735), 2B-81-532Z-F (C1-08732), 2B-81-532Z-F (C1-08710), 2B-81-532Z-F (C1-08714), 2B-81-532Z-F (C1-08717), 2B-81-532Z-F (C1-08716), 2B-81-532Z-F (C1-08721), 2B-81-532Z-F (C1-08719), 2B-81-532Z-F (C1-08703), 2B-81-532Z-F (C1-08707), 2B-81-532Z-F (C1-08708), 2B-81-532Z-F (C1-08733), 2B-81-532Z-F (C1-08734), 2B-81-532Z-F (C1-08731), 2B-81-532Z-F (C1-08715), 2B-81-532Z-F (C1-08671), 2B-81-532Z-F (C1-08713), 2B-81-532Z-F (C1-08680), 2B-81-532Z-F (C1-08755), 2B-81-532Z-F (C1-08681), 2B-81-532Z-F (C1-08683), 2B-81-532Z-F (C1-08701), 2B-81-532Z-F (C1-08723), 2B-81-532Z-F (C1-08672), 2B-81-532Z-F (C1-08673), 2B-81-532Z-F (C1-08682), 2B-81-532Z-F (C1-08702), 2B-81-532Z-F (C1-08712), 2B-81-532Z-F (C1-08722), 2B-81-532Z-F (C1-08724), 2B-81-532Z-F (C1-08753), 2B-81-532Z-F (C1-08754), 2B-81-532Z-F (C1-08756), 2B-81-532Z-F (C1-08757), 2B-81-532Z-F (C1-08759), 2B-81-532Z-F (C1-08760), 2B-81-532Z-F (C1-08761), 2B-81-532Z-F (C1-08762), 2B-81-532Z-F (C1-08763), 2B-81-532Z-F (C1-08758), 2B-81-532Z-F (DP-02162), 2B-81-532Z-F (DP-02793), 2B-81-532Z-F (DP-02932), 2B-81-532Z-F (DP-02942), 2B-81-532Z-F (C1-09444), 2B-81-532Z-F (DP-03114), 2B-81-532Z-F (DP-03116), 2B-81-532Z-F (DP-03117), 2B-81-532Z-F (DP-03118), 2B-81-532Z-F (DP-03115), 2B-81-532Z-F (DP-03144), 2B-81-532Z-F (DP-03123), 2B-81-532Z-F (DP-03229), 2B-81-532Z-F (DP-03323), 2B-81-532Z-F (OR-04667), 2B-81-532Z-F (DP-03893), 2B-81-532Z-F (DP-03930), 2B-81-532Z-F (DP-04378), 2B-81-532Z-F (DP-04377), 2B-81-532Z-F (DP-04386), 2B-81-532Z-F (DP-04454), 2B-81-532Z-F (DP-04456), 2B-81-532Z-F (DP-04707), 2B-81-532Z-F (DP-04760), 2B-81-532Z-F (DP-04818), 2B-81-532Z-F (DP-05108), 2B-81-532Z-F (DP-05362), 2B-81-532Z-F (DP-05349), 2B-81-532Z-F (DP-05350), 2B-81-532Z-F (DP-05416), 2B-81-532Z-F (DP-05510), 2B-81-532Z-F (DP-05544), 2B-81-532Z-F (DP-05559), 2B-81-532Z-F (DP-05511), 2B-81-532Z-F (DP-05599), 2B-81-532Z-F (DP-05630), 2B-81-532Z-F (DP-05637), 2B-81-532Z-F (DP-05685), 2B-81-532Z-F (DP-06005), 2B-81-532Z-F (DP-06052), 2B-81-532Z-F (DP-06388), 2B-81-532Z-F (DP-06495), 2B-81-532Z-F (DP-06496), 2B-81-532Z-F (DP-06497), 2B-81-532Z-F (DP-06498), 2B-81-532Z-F (DP-06500), 2B-81-532Z-F (DP-06546), 2B-81-532Z-F (DP-06501), 2B-81-532Z-F (DP-06567), 2B-81-532Z-F (DP-07049), 2B-81-532Z-F (DP-07134), 2B-81-532Z-F (DP-07513), 2B-81-532Z-F (DP-07784), 2B-81-532Z-F (DP-07785), 2B-81-532Z-F (DP-07790), 2B-81-532Z-F (DP-08166), 2B-81-532Z-F (DP-08167); d. TB LEAD, 4F UN-SHROUDED ATRIAL J-TIP, 020010 - 2B-81-532Z-J (C1-06957), 2B-81-532Z-J (DP-01059), 2B-81-532Z-J (DP-04648); e. TB LEAD, 5F UN-SHROUDED ATRIAL J-TIP, 020011 - 2B-81-532Z-K (C1-06940), 2B-81-532Z-K (D1-02916), 2B-81-532Z-K (D1-02559), 2B-81-532Z-K (OR-04406), 2B-81-532Z-K (DP-04647); f. TB LEAD, 6F UN-SHROUDED ATRIAL J-TIP, 020012 - 2B-81-532Z-L (D1-02565), 2B-81-532Z-L (OR-04370), 2B-81-532Z-L (DP-04649); g. TB LEAD, 4F UN-SHROUDED 60 DEG CURVE, 020016 - 2B-81-532Z-P (C1-06952), 2B-81-532Z-P (DP-01058); h. TB LEAD, 5F UN-SHROUDED 60 DEG CURVE, 020017 - 2B-81-532Z-Q (OR-04416), 2B-81-532Z-Q (DP-03054); i. TB LEAD, 6F UN-SHROUDED 60 DEG CURVE, 020018 - 2B-81-532Z-R (D2-01777), 2B-81-532Z-R (OR-03879), 2B-81-532Z-R (D1-02490), 2B-81-532Z-R (D2-01991), 2B-81-532Z-R (D1-02567), 2B-81-532Z-R (DP-01105), 2B-81-532Z-R (DP-01359), 2B-81-532Z-R (OR-04277), 2B-81-532Z-R (OR-04280), 2B-81-532Z-R (DP-01357), 2B-81-532Z-R (DP-01490), 2B-81-532Z-R (OR-04371), 2B-81-532Z-R (OR-04383), 2B-81-532Z-R (DP-06207); j. TB LEAD, 4F UNSHROUDED RIGHT HEART CURVE, 020022 - 2B-81-532Z-V (DP-02185), 2B-81-532Z-V (DP-03321), 2B-81-532Z-V (DP-04708), 2B-81-532Z-V (DP-04709), 2B-81-532Z-V (DP-05354), 2B-81-532Z-V (DP-05415), 2B-81-532Z-V (DP-05414), 2B-81-532Z-V (DP-06061), 2B-81-532Z-V (DP-06760), 2B-81-532Z-V (DP-07891); k. TB LEAD, 5F UN-SHROUDED RIGHT HEART CURVE, 020023 - 2B-81-532Z-W (D1-02822), 2B-81-532Z-W (D1-02817), 2B-81-532Z-W (D1-02924), 2B-81-532Z-W (D1 02817), 2B-81-532Z-W (C1-08091), 2B-81-532Z-W (C1-08096), 2B-81-532Z-W (C1-08098), 2B-81-532Z-W (C1-08095), 2B-81-532Z-W (C1-08097), 2B-81-532Z-W (C1-08133), 2B-81-532Z-W (C1-08134), 2B-81-532Z-W (DP-01116), 2B-81-532Z-W (C1-08135), 2B-81-532Z-W (C1-08101), 2B-81-532Z-W (C1-08121), 2B-81-532Z-W (C1-08124), 2B-81-532Z-W (C1-08123), 2B-81-532Z-W (C1-08128), 2B-81-532Z-W (C1-08137), 2B-81-532Z-W (C1-08099), 2B-81-532Z-W (C1-08103), 2B-81-532Z-W (C1-08104), 2B-81-532Z-W (C1-08106), 2B-81-532Z-W (C1-08112), 2B-81-532Z-W (C1-08113), 2B-81-532Z-W (C1-08114), 2B-81-532Z-W (C1-08115), 2B-81-532Z-W (C1-08117), 2B-81-532Z-W (C1-08118), 2B-81-532Z-W (C1-08120), 2B-81-532Z-W (C1-08126), 2B-81-532Z-W (C1-08127), 2B-81-532Z-W (C1-08136), 2B-81-532Z-W (C1-08092), 2B-81-532Z-W (C1-08100), 2B-81-532Z-W (C1-08105), 2B-81-532Z-W (C1-08107), 2B-81-532Z-W (C1-08108), 2B-81-532Z-W (C1-08109), 2B-81-532Z-W (C1-08110), 2B-81-532Z-W (C1-08119), 2B-81-532Z-W (C1-08129), 2B-81-532Z-W (C1-08130), 2B-81-532Z-W (C1-08131), 2B-81-532Z-W (C1-08132), 2B-81-532Z-W (C1-08093), 2B-81-532Z-W (C1-08094), 2B-81-532Z-W (C1-08102), 2B-81-532Z-W (C1-08111), 2B-81-532Z-W (C1-08122), 2B-81-532Z-W (DP-01372), 2B-81-532Z-W (DP-01434), 2B-81-532Z-W (DP-01596), 2B-81-532Z-W (OR-04381), 2B-81-532Z-W (OR-04382), 2B-81-532Z-W (OR-04405), 2B-81-532Z-W (DP-02792), 2B-81-532Z-W (OR-04579), 2B-81-532Z-W (DP-02933), 2B-81-532Z-W (DP-02940), 2B-81-532Z-W (DP-02949), 2B-81-532Z-W (OR-04600), 2B-81-532Z-W (OR-04625), 2B-81-532Z-W (OR-04609), 2B-81-532Z-W (OR-04709), 2B-81-532Z-W (C1-11368), 2B-81-532Z-W (C1-11369), 2B-81-532Z-W (C1-11370), 2B-81-532Z-W (C1-11371), 2B-81-532Z-W (C1-11374), 2B-81-532Z-W (C1-11375), 2B-81-532Z-W (C1-11376), 2B-81-532Z-W (C1-11377), 2B-81-532Z-W (C1-12452), 2B-81-532Z-W (C1 12452), 2B-81-532Z-W (DP-04710), 2B-81-532Z-W (DP-4763), 2B-81-532Z-W (DP-04778), 2B-81-532Z-W (OR-04842), 2B-81-532Z-W (DP-05418), 2B-81-532Z-W (DP 05418), 2B-81-532Z-W (DP-05899), 2B-81-532Z-W (DP-05967), 2B-81-532Z-W (DP-06761), 2B-81-532Z-W (DP-06985), 2B-81-532Z-W (DP-07012), 2B-81-532Z-W (DP-07791), 2B-81-532Z-W (DP-07792); l. TB LEAD, 6F UN-SHROUDED RIGHT HEART CURVE, 020024 - 2B-81-532Z-X (D2-01776), 2B-81-532Z-X (D2-01793), 2B-81-532Z-X (D1-02749), 2B-81-532Z-X (OR-04124), 2B-81-532Z-X (D1-02818), 2B-81-532Z-X (DP-01042), 2B-81-532Z-X (DP-01044), 2B-81-532Z-X (DP-01155), 2B-81-532Z-X (OR-04226), 2B-81-532Z-X (DP 01042), 2B-81-532Z-X (C1-07890), 2B-81-532Z-X (C1-07891), 2B-81-532Z-X (C1-07892), 2B-81-532Z-X (C1-07893), 2B-81-532Z-X (C1-07894), 2B-81-532Z-X (C1-07896), 2B-81-532Z-X (C1-07897), 2B-81-532Z-X (C1-07918), 2B-81-532Z-X (C1-07919), 2B-81-532Z-X (C1-07920), 2B-81-532Z-X (C1-07921), 2B-81-532Z-X (C1-07922), 2B-81-532Z-X (C1-07923), 2B-81-532Z-X (C1-07924), 2B-81-532Z-X (C1-07925), 2B-81-532Z-X (C1-07926), 2B-81-532Z-X (C1-07927), 2B-81-532Z-X (C1-07928), 2B-81-532Z-X (C1-07929), 2B-81-532Z-X (C1-07930), 2B-81-532Z-X (C1-07931), 2B-81-532Z-X (C1-07932), 2B-81-532Z-X (C1-07933), 2B-81-532Z-X (C1-07934), 2B-81-532Z-X (C1-07935), 2B-81-532Z-X (C1-07936), 2B-81-532Z-X (C1-07937), 2B-81-532Z-X (C1-07938), 2B-81-532Z-X (C1-07898), 2B-81-532Z-X (C2-07889), 2B-81-532Z-X (C1-07895), 2B-81-532Z-X (OR-04274), 2B-81-532Z-X (C1-07943), 2B-81-532Z-X (C1-07944), 2B-81-532Z-X (DP-01438), 2B-81-532Z-X (DP-01375), 2B-81-532Z-X (OR-04325), 2B-81-532Z-X (DP-01573), 2B-81-532Z-X (DP-01597), 2B-81-532Z-X (DP-01584), 2B-81-532Z-X (DP-01677), 2B-81-532Z-X (DP-01683), 2B-81-532Z-X (OR-04376), 2B-81-532Z-X (OR-04378), 2B-81-532Z-X (OR-04375), 2B-81-532Z-X (OR-04379), 2B-81-532Z-X (OR-04374), 2B-81-532Z-X (C1-08600), 2B-81-532Z-X (C1-08654), 2B-81-532Z-X (C1-08599), 2B-81-532Z-X (C1-08653), 2B-81-532Z-X (OR-04377), 2B-81-532Z-X (C1-08630), 2B-81-532Z-X (C1-08626), 2B-81-532Z-X (C1-08617), 2B-81-532Z-X (C1-08618), 2B-81-532Z-X (C1-08629), 2B-81-532Z-X (C1-08622), 2B-81-532Z-X (C1-08631), 2B-81-532Z-X (OR-04401), 2B-81-532Z-X (C1-08624), 2B-81-532Z-X (C1-08623), 2B-81-532Z-X (C1-08628), 2B-81-532Z-X (C1-08625), 2B-81-532Z-X (C1-08602), 2B-81-532Z-X (C1-08615), 2B-81-532Z-X (C1-08614), 2B-81-532Z-X (C1-08613), 2B-81-532Z-X (C1-08616), 2B-81-532Z-X (C1-08627), 2B-81-532Z-X (DP-03426), 2B-81-532Z-X (DP-03441), 2B-81-532Z-X (DP-03541), 2B-81-532Z-X (DP-03720), 2B-81-532Z-X (DP-04691), 2B-81-532Z-X (DP 04691), 2B-81-532Z-X (DP-04711), 2B-81-532Z-X (DP-04712), 2B-81-532Z-X (DP-04814), 2B-81-532Z-X (DP-04820), 2B-81-532Z-X (DP-05266), 2B-81-532Z-X (DP-05452), 2B-81-532Z-X (DP-05509), 2B-81-532Z-X (DP-05790), 2B-81-532Z-X (DP-05792), 2B-81-532Z-X (DP-05878), 2B-81-532Z-X (DP-05837), 2B-81-532Z-X (DP-05890), 2B-81-532Z-X (DP-05915), 2B-81-532Z-X (DP-05517), 2B-81-532Z-X (DP-05891), 2B-81-532Z-X (DP-07985); m. TB LEAD 4F UNSHROUDED CONVENIENCE KIT, TBK04110USG - 3H-81-003Z-A (DP-03329); n. TB LEAD 5F UNSHROUDED CONVENIENCE KIT, TBK05110USG - 3H-81-005Z-A (DP-01161), 3H-81-005Z-A (DP-02004), 3H-81-005Z-A (DP-02009), 3H-81-005Z-A (DP-02435), 3H-81-005Z-A (DP-02884), 3H-81-005Z-A (DP02884), 3H-81-005Z-A (DP 02884), 3H-81-005Z-A (DP-07032); o. TB 6F U CONVENIENCE KIT ADELANTE SIGMA PLUS 6F S10CM D15CM, TBK06110USG - 3H-81-007Z-A (D1-02232), 3H-81-007Z-A (D1-02520), 3H-81-007Z-A (D1-02833), 3H-81-007Z-A (DP-01376), 3H-81-007Z-A (DP-02083), 3H-81-007Z-A (DP-02408), 3H-81-007Z-A (DP-02885), 3H-81-007Z-A (DP-03724), 3H-81-007Z-A (DP-04453), 3H-81-007Z-A (DP-05047), 3H-81-007Z-A (DP-06146), 3H-81-007Z-A (DP-06147), 3H-81-007Z-A (OR-04888), 3H-81-007Z-A (DP-07005), 3H-81-007Z-A (DOR05934); p. TBRH 4F RT HEART CURVE U CONV. KIT ADELANTE SIGMA PLUS 4F S10CM D15CM, TBRHK04110USG - 3H-81-043Z-A (DP-03330), 3H-81-043Z-A (DP-04258); q. TBRH 5F RT HEART CURVE U CONV. KIT ADELANTE SIGMA PLUS 5F S10CM D15CM, TBRHK05110USG - 3H-81-041Z-A (DP-03051); r. TBRH 6F RT HEART CURVE U CONV. KIT ADELANTE SIGMA PLUS 6F S10CM D15CM, TBRHK06110USG - 3H-81-034Z-A (FP-054291), 3H-81-034Z-A (FP-54291), 3H-81-034Z-A (C1-08813), 3H-81-034Z-A (DP-02166); s. TBV 4F 60 DEGREE U CONV. KIT ADELANTE SIGMA PLUS 4F S10CM D15CM, TBVK04110USG - 3H-81-045Z-A (DP-03397); t. TBJ 4F ATRIAL J CURVE U CONV. KIT ADELANTE SIGMA PLUS 4F S10CM D15CM, TBJK04110USG - 3H-81-047Z-A (DP-03396); u. TBV 6F 60 DEGREE U CONV. KIT ADELANTE SIGMA PLUS 6F S10CM D15CM, TBVK06110USG - 3H-81-035Z-A (FP-55411) |
Recalling Firm/
Manufacturer |
Oscor, Inc.
3816 Desoto Blvd
Palm Harbor FL 34683-1618
|
| For Additional Information Contact |
Sonia Bermudez
727-937-2511
|
Manufacturer Reason
for Recall |
During the use of some TB - Temporary Bipolar Pacing Leads, featuring the 2mm unshrouded connectors, the connector cap housing may slide and potentially expose the connection wire. In some instances, this may cause the wire to be more susceptible to loss of connectivity or breakage during movement of the cables causing interruption of the pacing system.
|
FDA Determined
Cause 2 |
Device Design |
| Action |
A press release for the recall was issued on 09/27/2018. Additionally, starting on about 09/26/2018, Oscor notified customers via email and mail with a "PRODUCT RECALL - ACTION REQUIRED" letter. For distributors, instructions included to examine inventory for affected devices, quarantine any affected devices, notify customers if the affected devices have been further distributed, retrieve those affected devices from customers, and complete and return the attached Exhibit A. Any affected devices on hand and at customers should not be destroyed, but returned to Oscor.
For hospitals, instructions included to examine inventory for affected devices, quarantine any affected devices, and complete and return the attached Exhibit A. Any affected devices on hand and at customers should not be destroyed, but returned to Oscor.
Questions can be directed to TB Recall Coordinator at 727-937-2511 or e-mail TB@Oscor.com. Oscor business hours are Monday to Friday from 8:30AM to 5:30PM Eastern Time.
On 11/07/2018 Oscor expanded the recall and notified customers via "PRODUCT RECALL - ACTION REQUIRED" letter and press release. The expansion includes expired devices distributed by Oscor from 12/21/2011 to 04/30/2015, to result in affected devices distributed from 12/21/2011 to 05/17/2018. Instructions for distributors and hospitals remain the same as the original notification. |
| Quantity in Commerce |
36,688 units |
| Distribution |
Worldwide Distribution - US Nationwide in the states of AL, AZ, CA, CO, FL, HI, IN, KS, KY, LA, MA, MD, MI, MO, NC, NE, NJ, NM, NV, NY, OH, OK, OR, PR, RI, TN, TX, UT, VA, WA.
Countries of AUSTRIA, BENIN REPUBLIC, BOLIVIA, BRAZIL, BULGARIA, CANADA, COLOMBIA, COSTA RICA, DOMINICAN REPUBLIC, ECUADOR, EGYPT, EL SALVADOR, GEORGIA, GERMANY, GREECE, GUATEMALA, INDIA, IRAN, IRAN, ISRAEL, ITALY, JORDAN, KAZAKHSTAN, KUWAIT, LATVIA, LEBANON, MACEDONIA, MAURITIUS, MEXICO, NEW ZEALAND, PAKISTAN, PANAMA, PERU, PHILIPPINES, POLAND, RUSSIA,
SAUDI ARABIA, SENEGAL, SOUTH AFRICA, TAIWAN, TURKEY, UKRAINE,
UNITED ARAB EMIRATES, UNITED KINGDOM, VENEZUELA, VIETNAM. |
| Total Product Life Cycle |
TPLC Device Report
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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.
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| 510(K) Database |
510(K)s with Product Code = LDF and Original Applicant = OSCOR MEDICAL CORP.
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