Recall Z-1442-2015 ยท DQX Wire, Guide, Catheter
Baylis Medical Corp *
ProTrack Microcatheter; Product Usage: The ProTrack Microcatheter is a sterile, single use device intended to be used as a standard infusion wire or as an exchange guide for exchanging guidewires.
| Date | Apr 13, 2015 (initiated Mar 30, 2015) |
| Status | Terminated |
| Reason | Baylis Medical Company is recalling two lots of ProTrack Microcatheter due to the possibility that the catheter may have circumferential defects along its shaft. |
| Root cause | Process control |
| Action | A recall notification, marked "URGENT" will be sent by Baylis Medical via overnight courier to all customers affected by the recall with a fax-back form. The form is to be faxed back to Baylis Medical confirming receipt of the recall notice. As per instructions on the fax-back form, affected devices are requested to be returned. Baylis Medical will replace the returned affacted catheters with a new catheter. |
| Quantity | 58 units |
| Distribution | US Nationwide Distribution - US Nationwide in the states of MO, MA, OH, CA, AR, MA, FL, GA, CO, TX, KY, NY, MI, WI, OR |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K014075 | BMC COAXIAL INJECTABLE CATHETER, MODEL CIC 38/145 AND CIC 35/145 Baylis Medical Co., Inc., Mar 7, 2002 |