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Vaccine Administration Kit, Facility

Altitude Technologies Inc. · Model 04656 · UDI-DI 00850018892919

LRO Prescription
10
510(k) clearances
21,411
Adverse events (2 deaths)
1,077
Recalls
159
Facilities

Description

The Vaccine Administration Kit, Facility, contains the necessary items to prepare up to 100 patients for inoculation.

Recalls

DateFirmReason
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
2026-08-10AVID Medical, Inc.Product may be potentially contaminated with a lubricant used during the manufacturing process.
2026-08-10AVID Medical, Inc.Potential for product quality and sterility issues regarding kits containing Sodium Chloride ampules subject to recall by Spectra Medical.
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.
2026-08-10AVID Medical, Inc.Product may be potentially contaminated with a lubricant used during the manufacturing process.
2026-08-10Medline Industries, LPKits contain Healthmark Instrument Channel Brushes, which were recalled by the manufacturer due to the potential for a sharp edge/burr on the end of the brush. Potential hazards as
2026-08-10AVID Medical, Inc.Product may be potentially contaminated with a lubricant used during the manufacturing process.
2026-08-10Medline Industries, LPThe kits contain neurological sponges with the potential for unexpected variability of endotoxin levels. Potentially elevated endotoxin levels may present health risks that could r

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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.