Recall Z-2250-2011 ยท FCM Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)
Nurse Assist, Inc
Case Label: McKesson Medi-Pak Irrigation Tray With Thumb-Control Ring Piston Syringe Sterile Single Use Disposable Latex-Free 20 Trays Per Case Reorder No. 37-104 Marketed By McKesson Corporation McKesson Medical-Surgical, Richmond, VA 23228 Made in the U.S.A. Tray Label: McKESSON Medi-Pak Irrigation Tray With Thumb-Control Ring Piston Syringe Sterile Single Use Disposable Latex-Free Contents:
| Date | May 25, 2011 (initiated Jan 20, 2011) |
| Status | Terminated |
| Reason | The irrigation procedure trays contain Triad Group Alcohol Prep Pads recalled by Triad Group because they have the potential to be contaminated with an objectionable organism. |
| Root cause | Other |
| Action | The firm, Nurse Assist Incorporated, sent a letter dated January 20, 2011 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to examine their inventory immediately; quarantine the product; identify their customers and notify them at once about the product recall (Nurse Assist will provide bright labels to affix to your affected inventory); provide their customers with labels as well, and complete and return the attached RECALL ACKNOWLEGEMENT form via fax to: 817-231-1500 or mail to: Nurse Assist, Inc., 3400 Northern Cross Blvd., |
| Quantity | 18,320 cases |
| Distribution | Worldwide distribution: USA (nationwide) and countries including: Canada, Dubai and Saudi Arabia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.