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Cardinal Health FDA Recalls
20 recalls on file across devices, 3 of them Class I and 20 still open. Matched by name to CAH.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 mm), 5 mL Catheter Pre-connected to 1000 mL Drainage Bag PClass IINov 1, 2022Occlusion (blockage) of the bubble inlet port of the urinary |
| Dover Closed Urethral Tray with Hydrogel Coated Red Rubber Catheter 16 Fr/Ch (5.3 mm) Product Code: 3408 Intended for Class IINov 1, 2022Occlusion (blockage) of the bubble inlet port of the urinary |
| Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 ml) 5ml Catheter Product Code: 2480 Intended for urinaryClass IINov 1, 2022Occlusion (blockage) of the bubble inlet port of the urinary |
| Dover Closed Urethral Tray with Vinyl Catheter 14 Fr/Ch (4.7 mm), 5 mL Catheter Pre-connected to 1000 mL Drainage Bag PClass IINov 1, 2022Occlusion (blockage) of the bubble inlet port of the urinary |
| Dover Closed Urethral Tray with Vinyl Catheter Product Code: 3420 Intended for urinary drainage from the bladder of aClass IINov 1, 2022Occlusion (blockage) of the bubble inlet port of the urinary |
| Dover Closed Urethral Tray with Hydrogel Coated Red Rubber Catheter 14 Fr/Ch (4.7 mm) Product Code: 3410 Intended foClass IINov 1, 2022Occlusion (blockage) of the bubble inlet port of the urinary |
| SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns X-large, X-long SKU: 9041ELClass IINov 2, 2021Potential for open packaging seals compromising the sterilit |
| SmartGown Breathable Surgical Gowns with raglan sleeves X-large, X-long, A-line SKU: 32474Class IINov 2, 2021Potential for open packaging seals compromising the sterilit |
| Cardinal Health Poly-Reinforced Surgical Gowns Large SKU: 9010Class IINov 2, 2021Potential for open packaging seals compromising the sterilit |
| Cardinal Health Poly-Reinforced Surgical Gowns X-large SKU: 9040Class IINov 2, 2021Potential for open packaging seals compromising the sterilit |
| Cardinal Health Poly-Reinforced Surgical Gowns XX-large SKU: 9070Class IINov 2, 2021Potential for open packaging seals compromising the sterilit |
| RoyalSilk Non-Reinforced Surgical Gowns Large SKU: 9518Class IINov 2, 2021Potential for open packaging seals compromising the sterilit |
| RoyalSilk Non-Reinforced Surgical Gowns X-large SKU: 9548Class IINov 2, 2021Potential for open packaging seals compromising the sterilit |
| SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-Large SKU: 9011Class IINov 2, 2021Potential for open packaging seals compromising the sterilit |
| RoyalSilk Non-Reinforced Surgical Gowns XXX-large, X-long SKU: 95998Class IINov 2, 2021Potential for open packaging seals compromising the sterilit |
| SmartSleeve Poly-Reinforced Breathable Sleeve Surgical Gowns-X-Large SKU: 9041Class IINov 2, 2021Potential for open packaging seals compromising the sterilit |
| RoyalSilk Non-Reinforced Surgical Gowns XX-large SKU: 9578Class IINov 2, 2021Potential for open packaging seals compromising the sterilit |
| Monoject 0.9% Sodium Chloride Flush Syringe, 3 mL Fill, STERILE, Product Code 8881570123 The proposed device is indiClass IAug 4, 2021Potential for the plunger to draw back after the air has bee |
| Monoject 0.9% Sodium Chloride Flush Syringe, 10 mL Fill, STERILE, Product Code 8881570121 The proposed device is indClass IAug 4, 2021Potential for the plunger to draw back after the air has bee |
| Monoject 0.9% Sodium Chloride Flush Syringe, 5mL Fill, STERILE, Product Code 8881570125 The proposed device is indicClass IAug 4, 2021Potential for the plunger to draw back after the air has bee |