Launcher Guiding Catheter Model #LA6EBU30. Used in the coronary or peripheral vascular system..
FDA Recall Z-1626-2016 · Posted None
Recalling FirmStryker Sustainability Solutions
Recall StatusTerminated
Product CodeBTR
Date Initiated2016-04-04
Date Terminated2016-07-13
Product Quantity2
Reason for Recall
Device packaging may not be sealed.
Firm Action
Customer notification letter was sent 04/04/2016.
The customer was provided the following instructions:
Use of the affected lots of the recalled product should be discontinued. A Recall
Effectiveness Check Form has been enclosed. Note that the recall is limited to the specific lot number shipped to facility.
Once inventory has been checked complete the Recall Effectiveness
Check Form. The form needs to be completed even if no affected product is
found.
Return the completed and signed Recall Effectiveness Check Form utilizing
one of the following methods:
Return to your local Stryker Sustainability Sales Representative
Email to [email protected], or
Mail to:
Stryker Sustainability Solutions
181 O West Drake Drive
Tempe, AZ. 85283
Attn: Jodie Rueckert
If the form indicates that any affected devices remain in inventory, a prepaid
shipping label will be issued for the return of the product. Customers will receive a
credit for all affected devices returned.
Adverse reactions or quality problems experienced with the use of this product
may be reported to:
Stryker Sustainability Solutions Complaint Hotline: +1(888) 888-3433x5555
http://www.stryker.com/productexperience/
The FDA's MedWatch Adverse Event Reporting program either online, by
regular mail, or by fax.
Root Cause
Process control
Distribution Pattern
US distribution to KY.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.