Recall Z-0356-2016 ยท DQX Wire, Guide, Catheter
Baylis Medical Corp *
ProTrack Microcatheter. Model/Catalog Numbers CIC38-145, CIC35-145. Sterile, single use device intended to be used as a standard infusion wire or as an exchange guide for exchanging guidewires. Coaxial Injectable catheter guide wire. Cardiovascular.
| Date | Dec 1, 2015 (initiated Oct 28, 2015) |
| Status | Terminated |
| Reason | Microcatheter may have circumferential defects (cracks) along its shaft. |
| Root cause | Process control |
| Action | Recall notification letter was sent to affected consignees on 10/28/2015 via courier. The letter contained a fax-back form to be completed by the consignee and sent to the quality department of the recalling firm. |
| Quantity | 433 units |
| Distribution | Nationwide Distribution. |
| 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 |