Bard Access Systems
Complete recall history across all FDA and CPSC categories — 24 total recalls
Bard Access Systems appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Device Recalls (24)
FDA medical device enforcement actions by Bard Access Systems
| Date | Product | Reason | Class |
|---|---|---|---|
| Dec 19, 2016 | MiniLoc¿ Safety Infusion Set Winged without Y-Injection Site. Product Code: S... | Bard Access Systems announces a voluntary field action for the SafeStep¿ Hube... | Class II |
| Dec 19, 2016 | SafeStep¿ Huber Needle Set with Y-Injection Site. Product Code: LH-0029YN. Pa... | Bard Access Systems announces a voluntary field action for the SafeStep¿ Hube... | Class II |
| Dec 9, 2016 | StatLock¿ CV Plus w/Pigtail. Product Code: CV0220CE & CV0220. Packaged as a s... | Bard Access Systems announces a voluntary field action for the StatLock¿ Cath... | Class II |
| Dec 9, 2016 | StatLock¿ PICC Plus Crescent Foam. Product Code: VPPCSP & VPPCSPCE. Packaged ... | Bard Access Systems announces a voluntary field action for the StatLock¿ Cath... | Class II |
| Jul 20, 2015 | Marketing brochures for the PowerPICC and PowerPICC SOLO catheters | Bard Access Systems is recalling marketing brochures for the PowerPICC¿ and P... | Class II |
| May 27, 2015 | PowerPICC SOLO Catheter with Sherlock 3CG TPS Stylet 4F Maximal Barrier Tray ... | Bard Access Systems is recalling PowerPICC Solo Catheter Kits due to incorrec... | Class III |
| May 27, 2015 | PowerPICC SOLO2 Catheter 4F Maximal Barrier Tray with Microintroducer (Single... | Bard Access Systems is recalling PowerPICC Solo Catheter Kits due to incorrec... | Class III |
| May 27, 2015 | PowerPICC SOLO Catheter with Sherlock 3CG (TPS) Stylet 5F Maximal Barrier Tra... | Bard Access Systems is recalling PowerPICC Solo Catheter Kits due to incorrec... | Class III |
| May 27, 2015 | PowerPICC SOLO Catheter with Tip Location System (TLS) Stylet 4F Nurse Full T... | Bard Access Systems is recalling PowerPICC Solo Catheter Kits due to incorrec... | Class III |
| Mar 13, 2015 | PowerLoc MAX Safety Winged Infusion Set, Product Code 0132215 The PowerLoc... | Bard Access Systems is conducting a field action due to the potential that an... | Class II |
| Nov 3, 2014 | GuardIVa Antimicrobial Hemostatic IV Dressing, REF FP-23-AD008, Manufacturer:... | Bard Access Systems is recalling GuardIVa (Ref. No. FP23AD006) from lot ASXHT... | Class II |
| Aug 8, 2014 | BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits... | Some unit packages of BD PosiFlush SF Saline Flush Syringe 10 mL may exhibit ... | Class II |
| Aug 8, 2014 | BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits... | Some unit packages of BD PosiFlush SF Saline Flush Syringe 10 mL may exhibit ... | Class II |
| Aug 8, 2014 | BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits... | Some unit packages of BD PosiFlush SF Saline Flush Syringe 10 mL may exhibit ... | Class II |
| Aug 8, 2014 | BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits... | Some unit packages of BD PosiFlush SF Saline Flush Syringe 10 mL may exhibit ... | Class II |
| Aug 8, 2014 | BD Posiflush Saline Flush Syringe 10 ml inlcuded in the following device kits... | Some unit packages of BD PosiFlush SF Saline Flush Syringe 10 mL may exhibit ... | Class II |
| Jun 24, 2014 | Bard Peripherally Inserted Central Catheter (PICC) and Dialysis catheter kits... | Potential for inadvertent scalpel stick injury involving the safety scalpel. | Class II |
| Feb 27, 2014 | PowerPort Slim Implantable Port, indicated for patient therapies requiring re... | Labeling discrepancy.The label states that the implantable port contains sili... | Class II |
| Dec 6, 2013 | MRI Low Profile Single Lumen port with Open-Ended 6.6Fr Silicone Catheter. Pr... | Bard Access Systems is recalling various Low Profile Port with 6.6 Fr Single ... | Class II |
| Dec 6, 2013 | Titanium Single Lumen Low-Profile port, with Pre-Attached open-Ended Silicone... | Bard Access Systems is recalling various Low Profile Port with 6.6 Fr Single ... | Class II |
| Jun 10, 2013 | StatLock CV Plus w/Pigtail, Catheter Stabilization Device Sterile EO Single U... | BARD Access Systems is recalling lot JUWJF283 of StatLock CV Plus Stabilizati... | Class II |
| Feb 21, 2013 | Hickman 9.0 French Dual Lumen Catheter with SureCuff Tissue Ingrowth Cuff wit... | Bard Access Systems is recalling two lots of Hickman 9.0 French and one lot o... | Class II |
| Feb 21, 2013 | Leonard 10.0 French Dual Lumen Catheter with SureCuff Tissue Ingrowth Cuff wi... | Bard Access Systems is recalling two lots of Hickman 9.0 French and one lot o... | Class II |
| Aug 7, 2012 | 16 Fr HemoStar XK Long-Term Hemodialysis Catheter, implanted Standard kit con... | Bard Access Systems is recalling one lot of 16 Fr HemoStar XK Long Term Hemod... | Class III |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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