Deroyal Surgical -Rose Hill
Rose Hill, VA
Deroyal Surgical -Rose Hill appears in FDA device records in Rose Hill, VA. FDA records list no 510(k) clearances, no PMA records and no registered establishments. As of , FDA records show 7 recalls for this company.
FDA records held for this company
- 510(k) clearances
- 0
- PMA records
- 0
- Recall records
- 7
- Registered establishments
- 0
510(k) clearance history
No 510(k) clearance records for this company in the ingested FDA data.
No 510(k) clearance records in the ingested FDA data.
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
No FDA product codes recorded against this company.
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1495-04 | Stockinette, Double Ply, Econo Weave, EZ Roll, 6 X 60'', 8 X 60'', Ref#9991-60, #9993-60 | Surgical drapes and covers were packaged in containers with incomplete seals which compromise product sterility. | Terminated | ||
| Z-1494-04 | Stockinette, Double Ply, Econo Weave, 6 X 54'', 6 X 60'', 6 X 72'', 8 X 48'', 8 X 72'', Ref #9984-54, #9984-54, #9985-60, #9986-72, #9987-48, #9988-60, #9988-72 | Surgical drapes and covers were packaged in containers with incomplete seals which compromise product sterility. | Terminated | ||
| Z-1493-04 | Stockinette, Double Ply, Standard Weave, 6 X 60'', 6 X 72'', 8 X 48'', 8 X 60'', 8 X 72'', 10 X 48'' | Surgical drapes and covers were packaged in containers with incomplete seals which compromise product sterility. | Terminated | ||
| Z-1492-04 | Stockinette, Single Ply, Standard Weave, 8 X 72'' and 10 X 48'', Ref #9508-72, #9510-48, #9510-48, #9510-60 | Surgical drapes and covers were packaged in containers with incomplete seals which compromise product sterility. | Terminated | ||
| Z-1491-04 | Stockinette, Single Ply Econo Weave, 8 X 72'', Ref #9999-72. | Surgical drapes and covers were packaged in containers with incomplete seals which compromise product sterility. | Terminated | ||
| Z-1490-04 | Impervious Stockinette, Large, 12'' X 48'' or 12'' X 54'', Ref #9806-54, #9816-54, and #9978-12; X-Large, 16'' X 48'', Ref #9978-16 | Surgical drapes and covers were packaged in containers with incomplete seals which compromise product sterility. | Terminated | ||
| Z-0708-03 | DeRoyal''s SurgiMate (tm) Skin Stapler, Rotating Head, product #25-1001, packaged with 35 or more stainless steel staples in peel away pouch. Pouch is labeled in part, ***sterile, disposable, do not resterilize***. Pouches are packaged 12 per box. | Non-sterile surgical medical device is labeled as sterile product. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain