Recall Z-2622-2010 ยท GCJ Laparoscope, General & Plastic Surgery
Stryker Endoscopy
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.
| Date | Sep 29, 2010 (initiated Jun 21, 2010) |
| Status | Terminated |
| Reason | Outer packaging seals have inconsistencies that have resulted in compromised seals and may result in compromised sterility. |
| Root cause | Process control |
| Action | 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 |
| Quantity | 191855 units |
| 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, C |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K053311 | STRYKER SCOPE WARMER Stryker Endoscopy, Jan 27, 2006 |