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CARDINAL HEALTH
Cardinal Health 200, LLC · Model SBA33APOBA · UDI-DI 10195594418199
LRO
Prescription
10
510(k) clearances
22,538
Adverse events (2 deaths)
1,080
Recalls
161
Facilities
Description
LAP PACK
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-09-02 | Medline Industries, LP | Medical convenience kits were distributed containing cannula components which do not conform to ISO 80369-7 dimensional requirements and may contribute to leaking or breaking durin |
| 2026-08-31 | Medline Industries, LP | Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potential for erroneous overpressure alerts and system venting during use, which may result |
| 2026-08-31 | Medline Industries, LP | Kits contain CONMED AirSeal Access Ports. The ports were recalled by manufacturer due to potential for erroneous overpressure alerts and system venting during use, which may result |
| 2026-08-18 | Cardinal Health 200, LLC | The kits contain tube sets with handpieces that may leak during use. The impacted devices can have the following failures: fluid leakage from the hand piece that can pool on the fl |
| 2026-08-11 | Medline Industries, LP | The kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillu |
| 2026-08-10 | AVID Medical, Inc. | Product may be potentially contaminated with a lubricant used during the manufacturing process. |
| 2026-08-10 | AVID Medical, Inc. | Product may be potentially contaminated with a lubricant used during the manufacturing process. |
| 2026-08-10 | AVID Medical, Inc. | Product may be potentially contaminated with a lubricant used during the manufacturing process. |
| 2026-08-10 | Medline Industries, LP | The kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present health risks that could r |
| 2026-08-10 | AVID Medical, Inc. | Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampules subject to recall by Spectra Medical. |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.