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CARDINAL HEALTH
Cardinal Health 200, LLC · Model SBA5BLPH10 · UDI-DI 10197106238370
FDE
Prescription
4
510(k) clearances
554
Adverse events (2 deaths)
127
Recalls
44
Facilities
Description
HENNEPIN LAPAROSCOPIC 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 |
| 2026-08-26 | GRI Medical & Electronic Technology Co., Ltd. | Laparoscopy packs labeled as "latex free" were found to contain a latex urethral catheter |
| 2026-08-10 | American Contract Systems Inc | Kits contain manufacturer-recalled perineal care (pericare) wipes within urinary catheter trays, which may be contaminated with a lubricant used during the manufacturing process. U |
| 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 |
| 2026-07-31 | Medline Industries, LP | Kits may exhibit open seals in sterile pouch packaging. Open seal may compromise product sterility. If not detected prior to use, issue may lead to contamination of sterile field o |
| 2026-07-29 | Cardinal Health 200, LLC | The Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing process. If a contaminated wipe is |
| 2026-07-10 | Medline Industries, LP | Kits contain a potentially contaminated component which were recalled by the manufacturer |
| 2026-06-12 | Medline Industries, LP | The kits contain BD ChloraPrep Clear - 1 mL and FREPP Clear 1.5 mL Applicators which have a potential breach of sterility in the packaging, due to wrinkles in the paper lidding whi |
| 2026-05-04 | Medline Industries, LP | During an internal review, Medline identified representative samples did not meet applicable performance specifications. Identified issues include irregularities in catheter surfac |
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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.