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CARDINAL HEALTH

Cardinal Health 200, LLC · Model SBA69RPS19 · UDI-DI 10198956161498

LRO Prescription
10
510(k) clearances
22,538
Adverse events (2 deaths)
1,085
Recalls
162
Facilities

Description

ROBOTICS PACK SOUTH SAC

Recalls

DateFirmReason
2026-09-24Cardinal Health 200, LLCKits contain infusion sets which were recalled for performance issues.
2026-09-08AVID Medical, Inc.A non-sterile component was piggybacked and incorrectly placed outside of the sterile barrier and not subjected to EO sterilization per kit specifications.
2026-09-08AVID Medical, Inc.Shelf label of kit is mislabeled as "Extremity" instead of "Arthroscopy Pack."
2026-09-08AVID Medical, Inc.Potential for open seals on header bags, compromising sterility.
2026-09-08AVID Medical, Inc.A non-sterile component was piggybacked and incorrectly placed outside of the sterile barrier and not subjected to EO sterilization per kit specifications.
2026-09-02Medline Industries, LPMedical 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
2026-08-31Medline Industries, LPKits 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
2026-08-31Medline Industries, LPKits 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
2026-08-18Cardinal Health 200, LLCThe 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
2026-08-11Medline Industries, LPThe kits contain certain lots of sterile applicators which may contain fungal contamination that may occur under certain environmental conditions, allowing the growth of Aspergillu

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Data 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.