Reported May 27, 2015 · Terminated
DeRoyal(R) Medium Specimen Retrieval Bag, REF 5500-000-003, Rx Only Product Usage: The device is a single-use specimen…
DeRoyal Industries Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: DeRoyal Industries Inc · 200 Debusk Ln · Powell, TN · 37849-4703
Is this the product you have?
- DeRoyal(R) Medium Specimen Retrieval Bag, REF 5500-000-003
- Rx Only Product UsageThe 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
- Lot codes and dates
1211QDA4031301QDA4021301QDA4101303QDA401211QDA4033204656432119911323383813256225132783812328864413289105132899882329426093311427434939294352299303557999935738515
- Amount recalled
- 5359 units
Where it was sold
- Nationwide
Why it was recalled
The firm received reports of specimen retrieval bags tearing, ripping, and coming apart during use.
This product could cause temporary or reversible health problems — stop using it.
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