Kits and Trays containing both alcohol swabstick/prep pad and lubricant: DeRoyal (R) AMNIOCENTESIS TRAY, LINK DREW LACO

FDA device recall Z-2228-2011 · posted 2011-05-20 · Terminated

Recall details

Recalling firm

Deroyal Industries, Inc. Lafollette

Reason for recall

Custom surgical kits contained either one or more of the following possible contaminated recalled products: Triad lubricating jelly, alcohol prep pads, and alcohol swabs.

Action taken

DeRoyal notified their consignees by letter with the subject line "Re: DeRoyal Recall of Triad Medical Lubricating Jelly, Alcohol Prep Pads and Alcohol Swabs" on 02/07/2011 that kits in their possession contained recalled Triad products that were possibly contaminated. Customers were to use the attached spreadsheet to identify and quarantine the affected product. The spreadsheet should have been completed even if there was no affected product. The form should have been faxed back to 865-362-3716 or emailed to recalls@deroyal.com. Customers' DeRoyal Sales Representative would re-label the affected product in order to prevent further use. The DeRoyal Sales Representatives are also providing in-service training on effectuating this recall, including the importance of identifying, retrieving and discarding the recalled products as well as the documentation necessary to account for these products. Distributors were directed to recall down to the retail level. If there are questions or if further assistance is needed, customers can contact their DeRoyal Sales Representative or customer support department at 1-800-251-9864.

Root cause

Other

Status

Terminated

Product code

LRP

Quantity affected

340,976 units total

Distribution

Nationwide Distribution

Date initiated

2011-02-07

Date posted

2011-05-20

Date terminated

2014-08-06

Location

La Follette, TN