—#136431

Product

DeRoyal(R) Medium Specimen Retrieval Bag, REF 5500-000-003, Rx Only Product Usage: The device is a single-use specimen retrieval bag indicated for use in laparoscopic procedures to capture and remove organs or tissue from the body cavity.

FDA product code: GCJ — Laparoscope, General & Plastic Surgery
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K132375
Affected lot / code info: 1211QDA403, 1301QDA402, 1301QDA410, 1303QDA401, 211QDA403, 32046564, 32119911, 32338381, 32562251, 32783812, 32886441, 32891051, 32899882, 32942609, 33114274, 34939294, 35229930, 35579999, 35738515

Why it was recalled

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

Root cause (FDA determination)

Device Design

Action the firm took

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.

Recalling firm

Firm: DeRoyal Industries Inc
Address: 200 Debusk Ln, Powell, Tennessee 37849-4703

Distribution

Distribution pattern: US Nationwide Distribution

Timeline

Recall initiated: 2015-04-17
Posted by FDA: 2015-05-21
Terminated: 2015-12-29
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #136431. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.