510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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Z-0922-2011

Stryker brand Cart with Isolation Transformer, Model Numbers: 240-099-001, 240-099-001K, 240-099-011...

Stryker Corp. / initiated 2010-04-16 / Terminated / root cause: design
FDA source (opens on fda.gov)

Stryker Endoscopy began a recall of 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... on . The reason FDA records is "The electrical cord power plug design may allow the prongs to develop a fracture inside or outside the plug, if the plug is misused". As of , the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number
Z-0922-2011
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Stryker Corp.
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.
Product code
GCJ Laparoscope, General & Plastic Surgery
Reason for recall
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 tag
design
FDA root cause
Device Design
Action
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 [email protected]. For questions regarding this recall call the Stryker RA/QA Department at (408) 754-2738 or (800) 435-0220, Reference RA 2010-034.
Quantity in commerce
7371
Distribution
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.
Product codes and lots
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.