Medical Device Recall: Z-0016-2012

FDA Recalls dataset · Firm: Deroyal Industries, Inc. Lafollette · Status: Terminated

Recall Action Class: N/A Date Initiated: 2011-08-23 Recall record compiled from public FDA source records.

Recall Parameters & Description

Normalized public record details for FDA recall code Z-0016-2012.

Recall Res Number
Z-0016-2012
Recalling Firm / Manufacturer
Deroyal Industries, Inc. Lafollette
FEI Number
3005011024
Recall Status
Terminated
Recall Classification
N/A
Date Initiated
2011-08-23
Date Posted
2011-10-06
Date Terminated
2013-01-30
Product Code
OFD
Event Number
59854
Product Quantity
200 units
Product Description 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.
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.
Action Details 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.
Distribution Pattern Nationawide Distribution USA - including the states of: CA, FL, GA, NJ, and WA.
Code Information / Serial Numbers Lot Numbers: 25402698, 25834829

Related Establishments / Registrations

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