Stryker Scope Warmer, disposable. Endoscopic accessory composed of polyvinyl Chloride (PVC) and Sodium Acetate, Model Number 502-360-000, manufactured by Stryker Endoscopy, San Jose, CA.
This recall has been terminated (originally issued September 29, 2010).
- Company
- Stryker Endoscopy
- Recall Initiated
- June 21, 2010
- Posted
- September 29, 2010
- Terminated
- December 16, 2010
- Recall Number
- Z-2622-2010
- Quantity
- 191855 units
- Firm Location
- San Jose, CA
- Official Source
- View on FDA website ↗
Reason for Recall
Outer packaging seals have inconsistencies that have resulted in compromised seals and may result in compromised sterility.
Distribution
Worldwide Distribution: USA, Including the states of AK, AL, AR, CA, CO,CT, DE, DC, FL, GA, HI, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MS, MO, MT, NE, NJ, NM, NH, NV, NC, ND, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, and WY, and the countries of Australia, Brazil, Canada, Chile, China,France, Germany, Iberia, India, Italy, Netherlands, New Zealand, Japan, Korea, Latin America, Polska, Singapore, South Africa, Switzerland, Thailand, and United Kingdom.
Lot / Code Info
Model number 502-360-000, all serial numbers
Root Cause
Process control
Action Taken
Stryker issued an Urgent Device Removal letter, dated June 21, 2010, to customers which identified the affected product, the sterility issue, and the actions to be taken by the customer. Customers were instructed to identify and quarantine any affected product in their inventory, and contact Stryker Customer Service at 800 624-4422 and request an RMA#. The RMA# is to be written on the outside of the package used to return products, using an enclosed pre-paid shipping label. All cusotmers are to complete and sign an enclosed "acknowledgement of receipt" and fax to (408) 754-8278. Stryker can be contacted at 800-624-4422.