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KITPACK

NETWORK MEDICAL PRODUCTS LIMITED · Model 1-905 · UDI-DI 05056100712584

HOZ
1
510(k) clearances
62
Adverse events
10
Recalls
74
Facilities

Description

PVA Instrument Wipe Bulk Packed Non-sterile - 300 Pieces 3"x3"x1mm

Recalls

DateFirmReason
2024-10-22Carwild CorporationPotential for package seal to be out of specification and the sterile barrier cannot be guaranteed for the life of the product.
2024-10-22Carwild CorporationPotential for package seal to be out of specification and the sterile barrier cannot be guaranteed for the life of the product.
2024-10-22Carwild CorporationPotential for package seal to be out of specification and the sterile barrier cannot be guaranteed for the life of the product.
2022-12-20Beaver Visitec International, Inc.Device packaging may contain open seals, compromising product sterility.
2022-11-02Stradis Medical, LLC dba Stradis HealthcareMedical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in
2022-05-25Mckesson Medical-Surgical Inc. Corporate OfficeFacility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 0
2013-08-12DeRoyal Industries IncOne lot of eye spears was labeled as being x-ray detectable, but contained non x-ray detectable product.
2003-01-08Ultracell Medical TechnologiesSterility of the device is compromised
2003-01-08Ultracell Medical TechnologiesSterility of the device is compromised
2003-01-08Ultracell Medical TechnologiesSterility of the device is compromised

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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.