Boston Scientific PT2 Moderate Support Guide Wire 300cm J-Tip, Catalog Number 38931-04. Sold in single pack and 5-pack.
FDA device recall Z-1541-06 · posted 2006-09-29 · Terminated
Recall details
- Recalling firm
- Boston Scientific
- Reason for recall
- The PT2 J-tip labeled guide wires may be missing the pre-formed J-tip. As a result, guide wires may have a straight tip instead of a pre-formed J-tip.
- Action taken
- An Urgent Medical Device Recall letter, dated 08/31/06, was sent to affected customers. The letter describes the issue,states that distribution or use of affected product should cease immediately and replacement product will be issued for all returned devices. A Reply Verification Tracking Form is asked to be completed and returned to Boston Scientific.
- Root cause
- Other
- Status
- Terminated
- Product code
- DQX
- Quantity affected
- 343 Total. 329-US, 14-Foreign
- Distribution
- Worldwide distribution --- including states of AR, AZ, CA, CO, CT, DE, FL, GA, IA, IL, IN, KY, LA, MA, MD, ME, MI, MN, MO, NC, NE, NJ, NM, NV, OH, OK, PA, SC, TN, TX, WI, WV and Puerto Rico and countr
- Date initiated
- 2006-08-31
- Date posted
- 2006-09-29
- Date terminated
- 2007-06-26
- Location
- Maple Grove, MN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PT2 GUIDE WIRE AND ADDWIRE EXTENSION WIRE (K030617) | Boston Scientific Scimed, Inc. | 2003-05-21 |