Geo-Med, TURP/CYSTO PACK PGYBK REF 89-7931.07, Rx Only, STERILE EO, Custom surgical kit.
FDA device recall Z-2678-2016 · posted 2016-08-26 · Terminated
Recall details
- Recalling firm
- DeRoyal Industries Inc
- Reason for recall
- The firm is recalling two custom surgical kits containing the BARD(TM) Toomey Irrigation Syringe 70cc with Resectoscope Tip, Catheter Tip, Luer Adapter and Cap. The BARD(TM) component is being recalled for a possible slit defect on the package that may affect the component's sterility.
- Action taken
- DeRoyal issued their recall on 08/11/2016 to the end-user level by sending overnight letters to its direct accounts. The customers were asked to identify the affected trays, place them in quarantine and return them to DeRoyal for replacement or credit.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- LRO
- Quantity affected
- 26 units
- Distribution
- Distributed in LA and TN.
- Date initiated
- 2016-08-11
- Date posted
- 2016-08-26
- Date terminated
- 2017-06-13
- Location
- Powell, TN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| GENERAL SURGERY TRAY (K842648) | Deroyal Industries, Inc. | 1984-09-20 |