Recall Z-1642-2015— DeRoyal Industries Inc
Class II · Terminated
Class II FDA medical device recall by DeRoyal Industries Inc, initiated 2015-04-17, terminated 2015-12-29. It names one FDA 510(k) clearance: K132375. 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.. Reason: The firm received reports of specimen retrieval bags tearing, ripping, and coming apart during use..
- Recalling firm
- DeRoyal Industries Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2015-04-17
- Terminated
- 2015-12-29
- Firm location
- Powell, TN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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.
Reason for recall
The firm received reports of specimen retrieval bags tearing, ripping, and coming apart during use.
Data sourced from openFDA. This site is unofficial and independent of the FDA.