ProTrack Microcatheter; Product Usage: The ProTrack Microcatheter is a sterile, single use device intended to be used as
FDA device recall Z-1442-2015 · posted 2015-04-13 · Terminated
Recall details
- Recalling firm
- Baylis Medical Corp *
- Reason for recall
- Baylis Medical Company is recalling two lots of ProTrack Microcatheter due to the possibility that the catheter may have circumferential defects along its shaft.
- Action taken
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- DQX
- Quantity affected
- 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
- Date initiated
- 2015-03-30
- Date posted
- 2015-04-13
- Date terminated
- 2016-11-17
- Location
- Montreal, Canada
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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 |