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Medline Industries, Inc.
CENTURION MEDICAL PRODUCTS CORPORATION · Model I502BF85HCNL · UDI-DI 10653160339663
OFD
Prescription
0
510(k) clearances
6
Adverse events
7
Recalls
16
Facilities
Description
STD, INTRO-FLEX INTRODUCER 8.5F, HC, NL
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-05-21 | Medline Industries, LP | The kits containing Huons Lidocaine HCL Injection USP 1% 10mg/ml 5mL Ampules (Lidocaine Ampules)(OEM). A recall notice was issued by Huons Co., Ltd. for Lidocaine Ampules due to qu |
| 2024-04-08 | MEDLINE INDUSTRIES, LP - Northfield | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that ma |
| 2024-04-08 | MEDLINE INDUSTRIES, LP - Northfield | Medical convenience kits contain plastic syringes affected by the FDA Safety Alert issued on March 19, 2024. Leaks, breakage, and/ other quality issues have been identified that ma |
| 2023-05-18 | MEDLINE INDUSTRIES, LP - Northfield | Probe covers for use during diagnostic ultrasound procedures may have an inadequate barrier at the seams. |
| 2023-05-15 | MEDLINE INDUSTRIES, LP - Northfield | Potential for the labeled sterile ultrasound gel component within packs to not meet sterility specifications. |
| 2022-11-04 | Medical Action Industries, Inc. 306 | XXX |
| 2011-08-23 | Deroyal Industries, Inc. Lafollette | The firm manufactured kits containing a HCH device, manufactured by Vital Signs, that was subsequently recalled because the product may have an occlusion that could prevent proper |
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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.