Recall Z-1876-2013 ยท DYB Introducer, Catheter
Medtronic Inc. Cardiac Rhythm Disease Management
Medtronic Mullins Transseptal Adult 7F, REF 008551. Intended for the introduction of cardiovascular catheters into the left side of the heart.
| Date | Aug 5, 2013 (initiated Jul 8, 2013) |
| Status | Terminated |
| Reason | Medtronic identified a specific labeling issue for specific lots of Mullins Transseptal Catheter Introducer Sheath, model 008551, in which packages labeled as Mullins 7F (French) may actually contain an 8F(French) dilator. Medtronic is requesting the return of potentially mis-labeled Mullins Transseptal Catheter Introducer 7 French Sheaths. Due to the differences in size, an 8F dilator will not |
| Root cause | Packaging change control |
| Action | Consignees were sent on 7/8/2013 a Medtronic, Inc " Urgent Medical Device Recall" letter dated 8 July 2013. The letter was addressed to Healthcare Professionals. The letter identified the problem and the product involved in the recall. Advised consignees to remove and quarantine the product from their inventory and return the product. Requested consignees to complete the attached Customer Confirmation Certificate and fax it to Medtronic at 651-367-0612. If the product has been further distributed advised consignees to please notify them of the recall. |
| Quantity | 269 |
| Distribution | Worldwide Distribution-USA (nationwide) including DC and the states of AZ, AK, CA, DE, GA, IL, KY, MA, MI, MN, MS, NV, NY, NC, OH, PA, TN, and TX, and the countries of AUSTRALIA, BRAZIL, CHILE, INDIA, and SINGAPORE. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K791963 | USCI MULLINS TRANSSEPTAL CATHETER INTRO. C.R. Bard, Inc., Nov 13, 1979 |