Recall Z-0016-2012 ยท OFD Catheter Introducer Kit
Deroyal Industries, Inc. Lafollette
DeRoyal (R) Heat/Moist Exchange, REF 83-000042, Rx Only, NON-STERILE, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk Lane, Powell, TN 37849, USA: Intended Use: Varies by kit; an anesthesia breathing circuit is a device that is intended to administer medical gases to a patient during anesthesia. It provides both an inhalation and exhalation route and may include a connector, adaptor, and Y-
| Date | Oct 6, 2011 (initiated Aug 23, 2011) |
| Status | Terminated |
| Reason | The firm manufactured kits containing a HCH device, manufactured by Vital Signs, that was subsequently recalled because the product may have an occlusion that could prevent proper flow of medical gases or oxygen to the patient. |
| Root cause | Nonconforming Material/Component |
| Action | The firm, DeRoyal, sent a "URGENT: MEDICAL DEVICE RECALL" letter dated September 13, 2011 to its customers. The letter describes product, problem, and actions to be taken. Customers are instructed to identify inventory being recalled and place in quarantine to prevent further use. Constomers were asked to return affected product they have in inventory. DeRoyal will replace this product free of charge. Customers were asked to complete the attached Recall Response Spreadsheet and return as per the instructions. Constomers were asked to return affected product they have in inventory. DeRoya |
| Quantity | 200 units |
| Distribution | Nationawide Distribution USA - including the states of: CA, FL, GA, NJ, and WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.