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FDA Medical Device Recalls (openFDA)

DeRoyal Industries Inc: NOVAPLUS (TM), SUCTION CANISTER, 1200cc, RIGID, WITH ELBOW, Cat. No. V71-3001, Rx only, NON-STERILE, Made exclusively for Novation by DeRoyal, 200 DeBusk Lane, Powell, TN 37849 Most commonly used during medical medical emergencies and surgery to remove fluid and secretions from a patient.

Recall number
Z-0101-2011
Recalling firm
DeRoyal Industries Inc
Product
NOVAPLUS (TM), SUCTION CANISTER, 1200cc, RIGID, WITH ELBOW, Cat. No. V71-3001, Rx only, NON-STERILE, Made exclusively for Novation by DeRoyal, 200 DeBusk Lane, Powell, TN 37849 Most commonly used during medical medical emergencies and surgery to remove fluid and secretions from a patient.
Status
Terminated
Initiated
2010-07-01
Posted
2010-10-20
Terminated
2012-04-10
Reason
Suction canisters may crack during use
Root cause
Other
Action
DeRoyal sent a Recall letter dated July 1, 2010 to all their consignees via UPS Air. The letter identified the product, the problem, and action to be taken by the consignees. Consignees were to complete the Recall Response Form by checking their inventory for DeRoyal Suction Canisters V71-3001, Lot #22622679. Indicate the number of replacement products needed on the Recall Response Form, including the address, reference PO#, etc. to be used for the replacement products and fax the form to DeRoyal at 865-362-3755 no later than July 7, 2010. Recalled products were to be returned to DeRoyal via UPS Ground Attn: Quality Control 300 DeBusk Lane Powell, TN 37849 Once the recalled product was received by DeRoyal, the replacement product would be shipped per the instructions on the Recall Response Form. Distributors were to forward the recall notice to their end-users, or provide customer listing so that DeRoyal may contact them. For any questions or assistance regarding this recall call 865-362-1037.
Quantity
not on file
Distribution
Nationwide
Lot, serial or model codes
Lot Number 22622679
510(k) numbers
not on file
PMA numbers
not on file
Product code
KDQ
Firm FEI
1043214
Firm city
Powell
Firm state
TN
Firm country
not on file

Where this comes from

Register
FDA Medical Device Recalls (openFDA)
Publisher
U.S. Food and Drug Administration (openFDA)
File
device-recall-0001-of-0001.json.zip
sha256
b87518bfe2e8
Size
288210821 bytes
Published
2026-09-28
Read
2026-09-29T08:25:23.626Z
Source file
Source file retained · verify
Refresh due
2026-10-06

Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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