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.
Reported: May 27, 2015 Initiated: April 17, 2015 #Z-1642-2015
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.
Details
- Recalling Firm
- DeRoyal Industries Inc
- Units Affected
- 5359 units
- Distribution
- US Nationwide Distribution
- Location
- Powell, TN
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by DeRoyal Industries Inc. Units affected: 5359 units.
Why was this product recalled? ▼
The firm received reports of specimen retrieval bags tearing, ripping, and coming apart during use.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 27, 2015. Severity: Moderate. Recall number: Z-1642-2015.
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