ProTrack Microcatheter. Model/Catalog Numbers CIC38-145, CIC35-145. Sterile, single use device intended to be used as a
FDA device recall Z-0356-2016 · posted 2015-12-01 · Terminated
Recall details
- Recalling firm
- Baylis Medical Corp *
- Reason for recall
- Microcatheter may have circumferential defects (cracks) along its shaft.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- DQX
- Quantity affected
- 433 units
- Distribution
- Nationwide Distribution.
- Date initiated
- 2015-10-28
- Date posted
- 2015-12-01
- Date terminated
- 2016-11-17
- Location
- Montreal, Canada
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| BMC COAXIAL INJECTABLE CATHETER, MODEL CIC 38/145 AND CIC 35/145 (K014075) | Baylis Medical Co., Inc. | 2002-03-07 |