Z-0098-2015Class II

DeRoyal(R) SafeLiner Suction Canister Kit, SEMI-RIGID, 1000cc, REF 71-6518, NON-STERILE, Rx Only, general...

Name: Z-0098-2015 DeRoyal(R) SafeLiner Suction Canister Kit, SEMI-RIGID, 1000cc, REF 71-6518, NON-STERILE, Rx Only, general...
Creator: DeRoyal Industries Inc
Published: 2014-08-22
License: https://open.fda.gov/license/

DeRoyal Industries, Inc. / initiated 2014-08-22 / Terminated / root cause: manufacturing process

FDA source

DeRoyal Industries Inc began a recall of DeRoyal(R) SafeLiner Suction Canister Kit, SEMI-RIGID, 1000cc, REF 71-6518, NON-STERILE, Rx Only, general hospital on 2014-08-22. FDA classified it as Class II and gives the reason as "These lots of suction canisters and lids have an insufficient seal under low or intermittent suction condition". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0098-2015
Classification: Class II
Status: Terminated
Initiated: 2014-08-22
Posted: 2014-10-20
Terminated: 2015-04-15
Recalling firm: DeRoyal Industries, Inc.
Product: DeRoyal(R) SafeLiner Suction Canister Kit, SEMI-RIGID, 1000cc, REF 71-6518, NON-STERILE, Rx Only, general hospital
Product code: KDQ Bottle, Collection, Vacuum
Reason for recall: These lots of suction canisters and lids have an insufficient seal under low or intermittent suction condition.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: DeRoyal sent an Urgent Voluntary Recall letter dated August 22, 2014, to all affected consignees by overnight letter or by email. DeRoyal was to follow up with non-responding accounts before October 1, 2014. Customers were instructed to check their inventory for the affected product. If they have affected product, customers were instructed to destory both the liner and the lid and dispose of it according to their facility's procedures. Customers were instructed to return the included Notice of Destruction to [email protected] even if they no longer have affected product. Customers with questions were instructed to contact their DeRoyal Sales Representative or DeRoyal Customer Service at 1-800-251-9864. For questions regarding this recall call 865-362-2334.
Quantity in commerce: 5112 units
Distribution: Nationwide Distribution including MI, OH, IN, FL, WV, VA, MI, NC, and NY
Product codes and lots: Lot 364817213

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0098-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0097-2015	Class II	Terminated	Voluntary: Firm initiated	2014-10-29	2014-10-20
Z-0098-2015	Class II	Terminated	Voluntary: Firm initiated	2014-10-29	2014-10-20

Product code KDQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)