| | Class 2 Recall
Percutaneous Catheter |  |
| Date Posted |
February 20, 2013 |
| Recall Number |
Z-0868-2013 |
| Product |
Vascular Solutions, SuperCross Microcatheter, Sterilized using ethylene oxide, Rx Only, Model numbers 5300 - 5307, 5324, 5325, 5329, 5332, 5336, 5340, and 5341.
Product Usage:
The SuperCross catheter is intended to be used in conjunction with steerable guidewires to access discrete regions of the coronary and/or peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices and to subselectively infuse/deliver diagnostic and therapeutic agents |
| Code Information |
559450, 551750, 552370, 552761, 552840, 552954, 553267, 553647, 553931,
554269, 554270, 554413. 555958, 557192, 557824, 558222, 558894, 559827,
560215, 551751, 552371, 552841, 553090, 553218, 553434, 553529, 554029,
554268, 554271, 555759, 555953, 557251, 559570, 559981, 560253, 560079,
560080, 554123, 556182, 558905, 560114, 554210, 555991, 556842, 557253,
554209, 555223, 555992, 556536, 556747, 557124, 558327, 558991, 560115,
561206, 554208, 555490, 555993, 556674, 556843, 558018, 558798, 559707,
560433, 561207, 554040, 555007, 555224, 555358, 558542, 560434, 561459,
554122, 555008, 555225, 555994, 558992, 561208, 560221, 560222, 560223,
560995, 560996.
|
Recalling Firm/
Manufacturer |
Vascular Solutions, Inc.
6464 Sycamore Ct N
Maple Grove, Minnesota 55369-6032 |
| Consumer Instructions |
No consumer action necessary |
Reason for
Recall |
Vascular Solutions, Inc has discovered a potential problem with a number of lots of Supercross microcatheters. A potential for surface contamination on aged catheters was observed during in-house testing.
|
| Action |
Vascular Solutions sent an "Urgent Medical device Recall" letter dated January 28, 29013 to all affected customers. The letter identified the affected product, described the problem and actions to be taken. The letter advised customers to remove the product from their inventory and to complete and return the VSI Account Inventory Form. For questions contact your local Sales Representative. |
| Quantity in Commerce |
4731 |
| Distribution |
Worldwide Distribution - USA Nationwide including the states of AL, AZ, AR, CA, CO, CT, DE, CD, FL, GA, HI, ID, IL ,IN, IA, KY, LA, ME, MD, MA, MI,MN, MO, MT, NE, NV, NH, NJ, NM, NY, NC, ND, OH, OK, OR, PA, SC, SD, TN, TX, UT, VT VA, WA, WV, WI, WY and AUSTRIA, CANDA, DENMARK, FINLAND, FRANCE, GERMANY, GREECE, HUNGARY, ISRAEL,. ITALY, MEXICO, NETHERLANDS, NORWAY, SPAIN, SWEDEN, SWITZERLAND, TAIWAN, TURKEY, UNITED KINGDOM. |
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