Drugs & medicalClass II

DeRoyal Industries Inc recalls Custom medical procedure packs labeled as: a) CATH ANGIOGRAPHY DRAPE PACK, REF 89-7102; b) CHOLANGIOGRAPHY KIT, REF 89-7322; c) CATH LAB…

The outer package seal could be open, or compromised which affects the sterility of the procedure pack inside.

Read the official notice →
Date
2023-07-12
Country
United States
Brand
DeRoyal Industries
Product
Custom medical procedure packs labeled as: a) CATH ANGIOGRAPHY DRAPE PACK, REF 89-7102; b) CHOLANGIOGRAPHY KIT, REF 89-7322; c) CATH LAB…
Classification
Class II
Units
US Nationwide distribution.
Category
Drugs & medical
Source
FDA · Device

Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer

What to do

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. Ask the pharmacy or supplier about a replacement or refund.

General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.

More DeRoyal Industries recalls

  1. 2024-04-03
  2. US
    Drugs & medicalClass I

    DeRoyal Industries Inc recalls GeoMed Custom Tracecarts, REF Numbers: a) 53-1831 ORTHO TOTAL JOINT TRACECART, b) 53-1836 GENERAL SURGERY TRACECART

    DeRoyal manufactured and distributed Surgical Tracecarts that contain a Nurse Assist 16FR Silver Urine Meter Foley which were subsequently recalled.

    FDA · DeviceDeRoyal Industries IncFloridaOfficial notice →
  3. 2024-01-03
  4. US
    Drugs & medicalClass II

    DeRoyal Industries Inc recalls DeRoyal CARDIAC CATH SET-UP KIT PGYBK, REF 89-10572

    Kit were manufactured and distributed with Edwards Life Sciences TruWave Disposable pressure transducers which were subsequently recalled by Edwards Life Sciences.

    FDA · DeviceDeRoyal Industries IncUS: VirginiaOfficial notice →
  5. 2023-10-25
  6. US
    Drugs & medicalClass II

    DeRoyal Industries Inc recalls DeRoyal Head and Neck procedure kit, REF 89-4473, surgical convenience kit

    DeRoyal is recalling certain lots of surgical procedure pack products that contain the B.Braun Medical Norm-Ject 2 Piece Syringe. The recall is due to the potential for the sterile packaging barrier to be damaged due…

    FDA · DeviceDeRoyal Industries IncPennsylvaniaOfficial notice →
  7. 2023-06-14
  8. US
    Drugs & medicalClass II

    DeRoyal Industries Inc recalls Sterile custom surgical procedure packs (1) 89-10529.04, CNRV OR C-SECTION PACK, New River Valley Medical Center; and (2) 89-10567.05,…

    The custom procedure packs contain light handle covers that have been recalled by another firm.

    FDA · DeviceDeRoyal Industries IncUS Nationwide distribution in the state of VA.Official notice →
  9. 2023-03-29
  10. US
    Drugs & medicalClass II

    DeRoyal Industries Inc recalls DeRoyal SafeLiner Suction Canister, 1000cc, REF PHESL-1000B

    The reason for the voluntary recall is due to shrinkage of the canister lid. This shrinkage causes the lid not to contact the outer shell to create a seal and thus, it does not create and hold vacuum.

    FDA · DeviceDeRoyal Industries IncUS Nationwide distribution in the states of Arizona, Texas, Virginia,…Official notice →
  11. 2023-01-18
  12. US
    Drugs & medicalClass II

    DeRoyal Industries Inc recalls DeRoyal ORGAN RECOVERY PACK PGYBK, a) REF 89-9004.09 and b) 89-9004.10

    DeRoyal is recalling certain lots of surgical procedure pack products that contain a Medtronic Non-Absorbable Suture. The recall is due to Medtronic determining a manufacturing error in the packaging of the…

    FDA · DeviceDeRoyal Industries IncUS Nationwide distribution in the states of IL, MO.Official notice →
All 18 DeRoyal Industries recalls →

Other drugs & medical recalls in the United States

  1. 2023-07-12
  2. US
    Drugs & medicalClass III

    NeuMoDx Molecular Inc recalls NeuMoDx SARS-CoV-2 Assay -IVD intended for the qualitative detection of SARS-CoV-2 RNA from nasal, nasopharyngeal and oropharyngeal swabs…

    Potential for lot number discrepancies between the test strip packaging and the barcode label applied to the test strip that is read by the instrument for LOT 123909 of NeuMoDx SARS-CoV-2 Test Strips (REF 300800). The…

    FDA · DeviceNeuMoDx Molecular IncUS Nationwide distribution in the states of FL, MI, NM, NY, TN, TX.Official notice →
  3. US
    Drugs & medicalClass II

    Zimmer, Inc. recalls NexGen Precoat Stemmed Tibial Plate Size 5

    Device outer packaging was incorrectly labeled.

    FDA · DeviceZimmer, Inc.International distribution in the country of India.Official notice →
  4. US
    Drugs & medicalClass II

    Siemens Healthcare Diagnostics, Inc. recalls Aptio Automation Storage and Retrieval Module (SRM)

    A firmware error may lead to an incorrect association of test result(s) to a sample ID and therefore to an incorrect patient result. The mis-association of test results, or a delay in testing, may occur when all the…

    FDA · DeviceSiemens Healthcare Diagnostics, Inc.Worldwide distribution - US Nationwide distribution in the states of CA, CO,…Official notice →
  5. US
    Drugs & medicalClass II

    TEI Biosciences, Inc. recalls PriMatrix Ag Meshed; Dermal Repair Scaffold; Rx Only; Sizes 10x12 cm (2:1), 10x25 cm (2:1), 20x25 cm (1:1), 4x4 cm (2:1), 6x6 cm (2:1),…

    Possible out of specification endotoxin test results due to issues with in-process and finished goods endotoxin testing.

    FDA · DeviceTEI Biosciences, Inc.Domestic: Nationwide Distribution.Official notice →
  6. US
    Drugs & medicalClass II

    NeuroLogica Corporation recalls OmniTom/OmniTom Elite- X-ray computed tomography applications for anatomy that can be imaged in the 40 cm aperture, primarily head and…

    1. Wheels loosening over time with use of the device could lead to the inability to effectively drive the device and could lead to delay in patient treatment. 2.Batteries used to power the NL5000 device contain…

    FDA · DeviceNeuroLogica CorporationWorldwide distribution - US Nationwide and the countries of Australia, Canada,…Official notice →
  7. US
    Drugs & medicalClass II

    Waldemar Link GmbH & Co. KG (Mfg Site) recalls LinkSymphoKnee Distal Femoral Augment - Tilastan - Size. 7-8, Lateral-Right/Medial-Left, 5mm-Intended for primary and…

    Fixation screw was inserted through the wrong side of the augment (distal to proximal, as opposed to proximal to distal, which is the correct orientation).

    FDA · DeviceWaldemar Link GmbH & Co. KG (Mfg Site)US Nationwide distribution in the states of AL, IL, IN, LA, GA, NV, TX.Official notice →
See all drugs & medical recalls →