—#93289

Product

Stryker brand Cart with Isolation Transformer, Model Numbers: 240-099-001, 240-099-001K, 240-099-011, 240-099-011K, 240-099-020, 240-099-020K, 240-099-050, 240-099-072. 240-099-001, 240-099-001K, 240-099-011, 240-099-011K, 240-099-020, 240-099-020K, 240-099-050, 240-099-072, Product is manufactured and distributed by Stryker Endoscopy San Jose, CA The product is indicated for use in the carts include an isolation transfer and a power cord for connecting the transformer to an electrical outlet as means of providing power to the cart for the equipment it houses.

FDA product code: GCJ — Laparoscope, General & Plastic Surgery
Device class: Class 2
Medical specialty: Gastroenterology, Urology
510(k) numbers: K935234
Affected lot / code info: Model Numbers/First/Serial Numbers: 240-099-001, 240-099-001K; First Serial number: 070119AB001; 240-099-011, 240-099-011K; First Serial number :070112AD043; 240-099-020, 240-099-020K: First Serial number: 070123AG001 240-099-050; First Serial number: 061206AF001; 240-099-072; First Serial number: 081002AL001.

Why it was recalled

The electrical cord power plug design may allow the prongs to develop a fracture inside or outside the plug, if the plug is misused.

Root cause (FDA determination)

Device Design

Action the firm took

Stryker Endoscopy sent an URGENT: Device Recall letter dated April 16, 2010, to Stryker Sales reps and all customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to: Locate the affected units. Visually inspect each cord for damage. If the cord has bent or cracked prongs the unit should be taken out of service immediately. The customer was instructed to call a Regulatory Affairs Recall Representative at (408) 754-2738 for further instruction. If the cord did not show signs of damage, it could remain in service. An acknowledgement form was included to document confirmation of receipt of the letter. Upon completion of the power cord inspection, customers were to sign the acknowledgement form indicating that all of their units were inspected. Customers were asked to mail the form to Stryker Endoscopy or fax to (408) 754-8378 or scan the card and email to PowerCord@stryker.com. For questions regarding this recall call the Stryker RA/QA Department at (408) 754-2738 or (800) 435-0220, Reference RA 2010-034.

Recalling firm

Firm: Stryker Endoscopy
Address: 5900 Optical Ct, San Jose, California 95138-1400

Distribution

Distribution pattern: Worldwide Distribution - USA including AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, ID, IL, IN, IA, KS, KY, LA, MA, ME, MI, MN, MS, MO, MT, NE, NH, NJ, NM, NV, MY, NC, ND, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, WV, and WY and the countries of Canada, Chile, China, India, Korea, Mexico, Singapore, Taiwan and Latin America.

Timeline

Recall initiated: 2010-04-16
Posted by FDA: 2011-01-19
Terminated: 2011-01-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #93289. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.