https://plainrecords.com/brand/stradis-healthcare/New recalls of Stradis Healthcare from FDA, CPSC and NHTSA records.en-ushttps://plainrecords.com/recall/device/z-0931-2023/https://plainrecords.com/recall/device/z-0931-2023/Wed, 18 Jan 2023 00:00:00 +0000Potential for the outer bag having pinhole leaks near the seal, which may result in a breach in the sterility of the kit.https://plainrecords.com/recall/device/z-0481-2023/https://plainrecords.com/recall/device/z-0481-2023/Wed, 21 Dec 2022 00:00:00 +0000Medical 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 the sterility of the kit.https://plainrecords.com/recall/device/z-1688-2022/https://plainrecords.com/recall/device/z-1688-2022/Wed, 14 Sep 2022 00:00:00 +0000Potential for incomplete seals.https://plainrecords.com/recall/device/z-1552-2022/https://plainrecords.com/recall/device/z-1552-2022/Wed, 24 Aug 2022 00:00:00 +0000The sterile barrier may be compromised.https://plainrecords.com/recall/device/z-1132-2022/https://plainrecords.com/recall/device/z-1132-2022/Wed, 01 Jun 2022 00:00:00 +0000There is uncertainty about the integrity of the methods used to ensure the sterile barrier integrity.https://plainrecords.com/recall/device/z-0862-2022/https://plainrecords.com/recall/device/z-0862-2022/Wed, 13 Apr 2022 00:00:00 +0000The outer bag may be perforated or torn, which may result in a breach in the sterility of the kit.https://plainrecords.com/recall/device/z-0400-2022/https://plainrecords.com/recall/device/z-0400-2022/Wed, 29 Dec 2021 00:00:00 +0000This recall has been initiated to address bulk packed, non-sterile Intravascular Administration Sets that were erroneously distributed to fill orders for the sterile version of the same Intravascular Administration Set.https://plainrecords.com/recall/device/z-0126-2022/https://plainrecords.com/recall/device/z-0126-2022/Wed, 27 Oct 2021 00:00:00 +0000Firm unable to confirm that the tenaculum devices were produced in accordance with required design and manufacturing standards.https://plainrecords.com/recall/device/z-1992-2015/https://plainrecords.com/recall/device/z-1992-2015/Wed, 15 Jul 2015 00:00:00 +0000Convenience kits being recalled due to the recall by the manufacturer (Medtronic) of a component (Devon Light Glove) contained in the kits.