DeRoyal(R) Medium Specimen Retrieval Bag, REF 5500-000-003, Rx Only Product Usage: The device is a single-use specimen r

FDA device recall Z-1642-2015 · posted 2015-05-21 · Terminated

Recall details

Recalling firm

DeRoyal Industries Inc

Reason for recall

The firm received reports of specimen retrieval bags tearing, ripping, and coming apart during use.

Action taken

DeRoyal sent an Urgent: Voluntary Recall letter dated April 17, 2015 to their customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to 1. Check your inventory for the product and specific lot number from the attached Recall Response Form. 2. If you have affected inventory, please destroy it and dispose of it according to your facilitys procedures. 3. Record all information on the included Recall Response and Notice of Destruction forms. 4. If you purchase through a distributor, please indicate their name/location on the Notice of Destruction Form so that we may issue credit appropriately. 5. Return both forms to recalls@deroyal.com or 865-362-3716 (fax) even if you no longer have affected inventory. 6. Once we have received your Recall Response and Notice of Destruction forms, you will receive credit for destroyed product as indicated on the form. 7. If you are a distributor of these products, please forward this recall notice on to your end-users, or provide us with your customer listing and we will gladly contact them for you. For questions regarding this recall, please contact your DeRoyal Sales Representative or DeRoyal Customer Service at 1-800-251-9864.

Root cause

Device Design

Status

Terminated

Product code

GCJ

Quantity affected

5359 units

Distribution

US Nationwide Distribution

Date initiated

2015-04-17

Date posted

2015-05-21

Date terminated

2015-12-29

Location

Powell, TN

Related 510(k) clearances