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ACS
AMERICAN CONTRACT SYSTEMS, INC. · Model AMCL05P · UDI-DI 00191072207296
0
510(k) clearances
683
Adverse events (3 deaths)
93
Recalls
30
Facilities
Description
CATH LAB PACK
Recalls
| Date | Firm | Reason |
|---|---|---|
| 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. |
| 2026-07-10 | Medline Industries, LP | Kits contain a potentially contaminated component which were recalled by the manufacturer |
| 2026-06-17 | Windstone Medical Packaging, Inc. | Windstone Medical Packaging issued a recall for specific item(s) and lot(s) of Aligned Medical Solutions (AMS) convenience kits containing Elevaris Lidocaine HCl injection USP. El |
| 2026-05-28 | Medline Industries, LP | Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on th |
| 2026-05-28 | Medline Industries, LP | Kits contain Swan-Ganz catheters recalled by Becton Dickinson (BD). BD has received complaints of leaks/breakage involving failures of the (blue) proximal injectate lumen hub on th |
| 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 |
| 2026-05-19 | AVID Medical, Inc. | Defects in the silicone seal, which may result in "doming" of the silicone seal due to improper sealing, potentially leading to fluid occlusion or leakage. |
| 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 |
| 2026-04-30 | AVID Medical, Inc. | Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled by the manufacturer due to presence of particulates within fluid path of the Manifol |
| 2026-04-30 | AVID Medical, Inc. | Affected kits contain Medline Namic Angiographic Star Off Handle Manifolds, which were recalled by the manufacturer due to presence of particulates within fluid path of the Manifol |
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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.