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Cardiovascular Procedure Kit

FDA product code OEZ · Class 2 · Cardiovascular

0
Registered devices
1,609
Adverse events
231
Recalls
0
510(k) clearances

Devices with this code

ACS — AMERICAN CONTRACT SYSTEMS, INC.Merit Medical® — Merit Medical Systems, Inc.Merit Medical® — Merit Medical Systems, Inc.Merit Medical® — Merit Medical Systems, Inc.Merit Medical® — Merit Medical Systems, Inc.CARDINAL HEALTH — Cardinal Health 200, LLCCARDINAL HEALTH — Cardinal Health 200, LLCCARDINAL HEALTH — Cardinal Health 200, LLCMedline Industries, Inc. — MEDLINE INDUSTRIES, INC.CARDINAL HEALTH — Cardinal Health 200, LLCACS — AMERICAN CONTRACT SYSTEMS, INC.ACS — AMERICAN CONTRACT SYSTEMS, INC.Merit Medical® — Merit Medical Systems, Inc.Merit Medical® — Merit Medical Systems, Inc.CARDINAL HEALTH — Cardinal Health 200, LLCCARDINAL HEALTH — Cardinal Health 200, LLCCARDINAL HEALTH — Cardinal Health 200, LLCCARDINAL HEALTH — Cardinal Health 200, LLCCARDINAL HEALTH — Cardinal Health 200, LLCCARDINAL HEALTH — Cardinal Health 200, LLCMedline Industries, Inc. — MEDLINE INDUSTRIES, INC.Medline Industries, Inc. — MEDLINE INDUSTRIES, INC.NAMIC — MEDLINE INDUSTRIES, INC.NAMIC — MEDLINE INDUSTRIES, INC.

Recent recalls

DateFirmReason
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 leaki
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
2026-08-10AVID Medical, Inc.Product may be potentially contaminated with a lubricant used during the manufacturing process.
2026-08-10AVID Medical, Inc.Product may be potentially contaminated with a lubricant used during the manufacturing process.
2026-08-10American Contract Systems IncKits contain manufacturer-recalled perineal care (pericare) wipes within urinary catheter trays, which may be contaminated with a lubricant used during the manu
2026-08-10AVID Medical, Inc.Product may be potentially contaminated with a lubricant used during the manufacturing process.
2026-08-10AVID Medical, Inc.Product may be potentially contaminated with a lubricant used during the manufacturing process.
2026-07-29Cardinal Health 200, LLCThe Urinary Catheter Trays contain CliniClean Pericare Wipes which may potentially be contaminated with a lubricant used during the manufacturing process. If a
2026-07-20Medline Industries, LPDownstream recall - manufacturer recalled specific lots of BD ChloraPrep Clear - 1mL Applicators. Affected product may exhibit an open or incomplete seal on the
2026-07-14Cardinal Health 200, LLCCardinal Health was recently informed of a medical device recall from MEDICOM concerning the Ritmed Neurological Sponges. The recall is being issued due to unex

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.