Recall Z-0016-2012
Deroyal Industries, Inc. Lafollette · initiated August 23, 2011
Product
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-piece.
Codes / lots: Lot Numbers: 25402698, 25834829
Reason for recall
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.
FDA-determined cause: Nonconforming Material/Component
Action taken
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. DeRoyal will replace this product free of charge. Distributors were instructed to perform a sub-recall to their customers. Customers with questions should call 865-362-1037 between 9am and 5pm EST or email recalls@deroyal.com.
Details
- Recall number
- Z-0016-2012
- Initiated
- August 23, 2011
- Posted by FDA
- October 6, 2011
- Terminated
- January 30, 2013
- Product code
- OFD – Catheter Introducer Kit
- Quantity
- 200 units
- Distribution
- Nationawide Distribution USA - including the states of: CA, FL, GA, NJ, and WA.
- Recalling firm
- Deroyal Industries, Inc. Lafollette, La Follette, TN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0015-2012 | Custom anesthesia kits labeled as follows: (1) DeRoyal (R) Adult Exp Anesthesia Circuit…The firm manufactured kits containing a HCH device, manufactured by Vital Signs, that was subsequently… | 08/23/2011Terminated |