Z-0334-2018Class II

DeRoyal Sterile Custom kits containing Covidien-Dover(TM) Irrigation Tray with Piston Syringe Containing...

Name: Z-0334-2018 DeRoyal Sterile Custom kits containing Covidien-Dover(TM) Irrigation Tray with Piston Syringe Containing...
Creator: DeRoyal Industries Inc
Published: 2017-12-19
License: https://open.fda.gov/license/

DeRoyal Industries, Inc. / initiated 2017-12-19 / Terminated / root cause: manufacturing process

FDA source

DeRoyal Industries Inc began a recall of DeRoyal Sterile Custom kits containing Covidien-Dover(TM) Irrigation Tray with Piston Syringe Containing Medline Aplicare Povidone Iodine Prep Pads, labeled as... on 2017-12-19. FDA classified it as Class II and gives the reason as "DeRoyal manufactured custom sterile surgical kits containing the Covidien-Dover(TM) Irrigation Tray with Piston Syringe that contains the Medline Aplicare Povidone Iodine Prep Pads. The Prep Pads were subsequently...". 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-0334-2018
Classification: Class II
Status: Terminated
Initiated: 2017-12-19
Posted: 2018-01-12
Terminated: 2018-06-21
Recalling firm: DeRoyal Industries, Inc.
Product: DeRoyal Sterile Custom kits containing Covidien-Dover(TM) Irrigation Tray with Piston Syringe Containing Medline Aplicare Povidone Iodine Prep Pads, labeled as follows: (a) Shoulder Arthroscopy Pack 89-8686.01 (b) Shoulder Arthroscopy Pack 89-8686.02 (c) Knee Arthro Pack 89-8687.01 (d) Knee Arthro Pack 89-8687.02 Product Usage: general surgical
Product code: LRO General Surgery Tray
Reason for recall: DeRoyal manufactured custom sterile surgical kits containing the Covidien-Dover(TM) Irrigation Tray with Piston Syringe that contains the Medline Aplicare Povidone Iodine Prep Pads. The Prep Pads were subsequently recalled because Medline Aplicare determined the product would not support the 36 month expiration date listed on the label.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm, DeRoyal, sent an "URGENT! RECALL NOTICE" letter dated 12/19/2017 to its Consignees overnight. The letter describe the product, problem and actions to be taken. The Consignees were instructed to identify affected product; place in quarantine to prevent further use, and complete and return the Affected Products Listing form to DeRoyal via fax to 865-362-3716 or email to [email protected] no later than 1/15/2018, even if you no longer have any inventory. If you have questions or need assistance with the recall, please email [email protected] or call by phone 865-362-4203 or email us at [email protected].
Quantity in commerce: 226 kits
Distribution: Distributed to states of: CA and MO.
Product codes and lots: (a) Lot number: 38527131 (b) Lot numbers: 41450075, 41511034, 42143982, 44108769, 44274020, 44721168, 45599133, (c) Lot numbers: 38497294, 38564514, 40146320, 40990651 (d) Lot numbers: 41668816, 42839390, 44080575, 44871131, 45715430, 46232122

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0334-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0334-2018	Class II	Terminated	Voluntary: Firm initiated	2018-01-24	2018-01-12

Product code LRO

K842648Class IIGeneral Surgery TrayDeroyal Industries, Inc. / cleared 1984-09-20

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)