DeRoyal (R) Heat/Moist Exchange, REF 83-000042, Rx Only, NON-STERILE, Manufacturer: DeRoyal Industries, Inc. 200 DeBusk

FDA device recall Z-0016-2012 · posted 2011-10-06 · Terminated

Recall details

Recalling firm

Deroyal Industries, Inc. Lafollette

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 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.

Root cause

Nonconforming Material/Component

Status

Terminated

Product code

OFD

Quantity affected

200 units

Distribution

Nationawide Distribution USA - including the states of: CA, FL, GA, NJ, and WA.

Date initiated

2011-08-23

Date posted

2011-10-06

Date terminated

2013-01-30

Location

La Follette, TN