Recall Z-2468-2015 ยท NLM Laparoscope, General & Plastic Surgery, Reprocessed
Stryker Sustainability Solutions
Stryker Sustainability Solutions CB5LT Ethicon Endo-Surgery, Inc. Excel Trocar Sleeve w/Stability Sleeve 5mm x 100mm Reprocessed by Stryker Sustainability Solutions Product Usage: The Reprocessed Ethicon ENDOPATH XCEL Universal Trocar Stability Sleeve is a sterile single patient use device with a radiolucent sleeve. The trocar sleeve contains two seals that accommodate instruments 5mm in diameter
| Date | Aug 27, 2015 (initiated Jul 10, 2015) |
| Status | Terminated |
| Reason | Stryker Sustainability Solutions has received reports indicating that devices from one lot (lot# 3574704) were labeled as 100mm models (CB5LT) while the devices inside of the packaging were 75mm models (CB5ST). |
| Root cause | Labeling mix-ups |
| Action | On 07/10/15 the firm sent out notification letters to all customers. The letter states for the customer to discontinue use of the affected lot, and to use other trocar lots reporcessed by the firm. The firm requests that the Recall Effectiveness Check Form be completed. The firm is going to be sending a sales representative to the facilities to check inventory for the affected trocars. A Recall Effectiveness Check will also be completed. If the form indicates that affected devices remain in inventory a prepaid shipping label will be issued for the return of the product. Customers will re |
| Quantity | 90 devices |
| Distribution | U.S. Nationwide Distribution to the following states of:: NV, NM, TX, and MI. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K100080 | REPROCESSED TROCARS, MODEL B5LT AND CB5LT Ascent Healthcare Solutions, Mar 19, 2010 |