Recalls / —
—#104326
Product
Smith & Nephew, HD1200 Autoclavable Camera Head Catalog Number: 72203360 Product Usage: Endoscope & Accessories
- FDA product code
- GCJ — Laparoscope, General & Plastic Surgery
- Device class
- Class 2
- Medical specialty
- Gastroenterology, Urology
- 510(k) numbers
- K014158
- Affected lot / code info
- S/N: DDQ00051, DDQ00052, DDQ00057 DDQ00064, DDQ00068, DDQ00070 DDQ00071, DDQ00080, DDQ00083 DDQ00085, DDQ00093, DDQ00094 DDQ00096, DDQ00104, DDQ00108
Why it was recalled
HD1200 camera heads may cause image issues
Root cause (FDA determination)
Process design
Action the firm took
Smith Nephew sent an "URGENT PRODUCT RECALL NOTIFICATION" letter dated sent September 23, 2011 to all affected consignees. The letter identified the product, problem and actions to be taken. Consignees were instructed to complete requested information, return affected product and order replacement product. To return product and order replacement product, consignees were instructed to contact the Smith & Nephew Endoscopy Returns Group at 800-343-5717 (option 3) for a Return Authorization (RA) or send an email to endo.andreturns@smith-nephew.com. For questions call 405-917-8556.
Recalling firm
- Firm
- Smith & Nephew, Inc. Endoscopy Division
- Address
- 150 Minuteman Drive, Andover, Massachusetts 01810-1031
Distribution
- Distribution pattern
- Nationwide Distribution (USA) including the states of: MI, NH, OK.
Timeline
- Recall initiated
- 2011-09-23
- Posted by FDA
- 2011-10-21
- Terminated
- 2016-02-16
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #104326. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.