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Bard Access Systems

36 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
StatLock PICC Plus Crescent Foam. Product Code: VPPCSP & VPPCSPCE. Packaged as a single un recall (Z-0981-2017)Bard Access Systems2017-01-10
StatLock CV Plus w/Pigtail. Product Code: CV0220CE & CV0220. Packaged as a single unit wit recall (Z-0982-2017)Bard Access Systems2017-01-10
MiniLoc Safety Infusion Set Winged without Y-Injection Site. Product Code: S02022-75. Pack recall (Z-0985-2017)Bard Access Systems2017-01-10
SafeStep Huber Needle Set with Y-Injection Site. Product Code: LH-0029YN. Packaged as sing recall (Z-0986-2017)Bard Access Systems2017-01-10
Marketing brochures for the PowerPICC and PowerPICC SOLO catheters recall (Z-2808-2015)Bard Access Systems2015-09-23
PowerPICC SOLO Catheter with Sherlock 3CG TPS Stylet 4F Maximal Barrier Tray with Microint recall (Z-2047-2015)Bard Access Systems2015-07-08
PowerPICC SOLO Catheter with Sherlock 3CG (TPS) Stylet 5F Maximal Barrier Tray with Microi recall (Z-2048-2015)Bard Access Systems2015-07-08
PowerPICC SOLO Catheter with Tip Location System (TLS) Stylet 4F Nurse Full Tray with Micr recall (Z-2049-2015)Bard Access Systems2015-07-08
PowerPICC SOLO2 Catheter 4F Maximal Barrier Tray with Microintroducer (Single-Lumen) (Sher recall (Z-2050-2015)Bard Access Systems2015-07-08
PowerLoc MAX Safety Winged Infusion Set, Product Code 0132215 The PowerLoc MAX Safety Wing recall (Z-1560-2015)Bard Access Systems2015-04-30
Bard Peripherally Inserted Central Catheter (PICC) and Dialysis catheter kits containing S recall (Z-1443-2015)Bard Access Systems2015-04-14
BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: Bard Poly M recall (Z-1271-2015)Bard Access Systems2015-03-13
BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: PowerLoc Po recall (Z-1272-2015)Bard Access Systems2015-03-13
BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: SafeStep Po recall (Z-1273-2015)Bard Access Systems2015-03-13
BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: PowerGlide recall (Z-1274-2015)Bard Access Systems2015-03-13
BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits: Groshong Mi recall (Z-1275-2015)Bard Access Systems2015-03-13
GuardIVa Antimicrobial Hemostatic IV Dressing, REF FP-23-AD008, Manufacturer: Bard Access recall (Z-0493-2015)Bard Access Systems2014-12-01
PowerPort Slim Implantable Port, indicated for patient therapies requiring repeated access recall (Z-1300-2014)Bard Access Systems2014-03-27
MRI Low Profile Single Lumen port with Open-Ended 6.6Fr Silicone Catheter. Product Code 06 recall (Z-0814-2014)Bard Access Systems2014-01-23
Titanium Single Lumen Low-Profile port, with Pre-Attached open-Ended Silicone 6.6Fr Cathet recall (Z-0815-2014)Bard Access Systems2014-01-23
StatLock CV Plus w/Pigtail, Catheter Stabilization Device Sterile EO Single Use Only, C.R. recall (Z-1618-2013)Bard Access Systems2013-06-28
Hickman 9.0 French Dual Lumen Catheter with SureCuff Tissue Ingrowth Cuff with Peel-Apart recall (Z-0909-2013)Bard Access Systems2013-03-06
Leonard 10.0 French Dual Lumen Catheter with SureCuff Tissue Ingrowth Cuff with Peel-Apart recall (Z-0910-2013)Bard Access Systems2013-03-06
16 Fr HemoStar XK Long-Term Hemodialysis Catheter, implanted Standard kit containing an Ai recall (Z-2277-2012)Bard Access Systems2012-08-27
BardPort M.R.I. Implanted Port with Attachable 6 Fr. ChronoFlex Open-Ended Single-Lumen Ve recall (Z-1133-2012)Bard Access Systems2012-03-01
BardPort Titanium Implanted Port. Bard Access Systems. Assembled in Mexico. A totally impl recall (Z-3173-2011)Bard Access Systems2011-09-08
Bard Aspira Drainage Kit, Product Code 4991502. The Aspira Peritoneal Drainage system is i recall (Z-2959-2011)Bard Access Systems2011-08-08
Bard Aspira Dressing Kit, Product Code 4991503. The Aspira Peritoneal Drainage system is i recall (Z-2960-2011)Bard Access Systems2011-08-08
Bard Aspira Luer Adapter, Product Code 4991505. The Aspira Peritoneal Drainage system is i recall (Z-2961-2011)Bard Access Systems2011-08-08
Bard Aspira Valve Assembly/Repair Kit, Product Code 4991506. The Aspira Peritoneal Drainag recall (Z-2962-2011)Bard Access Systems2011-08-08
Site Rite Vision Ultrasound System, REF 9770032, Bard Access Systems, Inc. Intended for di recall (Z-2782-2011)Bard Access Systems2011-07-11
Bard PowerLine 6 Fr. Dual-Lumen Polyurethane Catheter with SureCuff Ingrowth Cuff, REF 070 recall (Z-2783-2011)Bard Access Systems2011-07-11
Groshong 3 Fr. Single-Lumen PICC Intermediate Tray with Safety Introducer, Reorder Number recall (Z-0865-2011)Bard Access Systems2011-01-06
PowerPort isp M.R.I Implanted Port without Suture Plugs with attachable 6F Chronoflex Poly recall (Z-1525-2010)Bard Access Systems2010-04-29
Huber Plus Non-Coring Needle Safety Infusion Set, 19g, 1 inch, Needless Y-site, REF 011901 recall (Z-0861-2010)Bard Access Systems2010-02-26
Huber Plus Non-Coring Needle Safety Infusion Set, 19g, 1 inch, REF 011901, Sterile EO, Ass recall (Z-0862-2010)Bard Access Systems2010-02-26

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