Boston Scientific Super Sheath and Super Sheath R/O Introducer Sheaths, Sterile EO, Manufactured by Togo Medikit Co., Lt
FDA device recall Z-0264-2012 · posted 2011-11-21 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corporation
- Reason for recall
- Boston Scientific is initiating a medical device recall removal regarding nine lots/batches of Super Sheath and Super Sheath R/O Introducer Sheaths. Boston Scientific was informed through product complaints that the 0.035" ID dilator may be labeled incorrectly as a 0.038" ID dilator.
- Action taken
- Boston Scientific sent an URGENT MEDICAL DEVICE RECALL REMOVAL -IMMEDIATE ACTION REQUIRED letter dated November 21, 2011. The letter described the product and the problem. Customers were instructed to segregate the affected product immediately and return it to Boston Scientific. Distributors were advised that the recall removal depth is to the hospital level and the recall removal notification should be forwarded to their customers. For questions regarding this recall call 763-494-1133.
- Root cause
- Packaging process control
- Status
- Terminated
- Product code
- DRE
- Quantity affected
- 2660
- Distribution
- Worldwide Distribution - USA including AZ, AR, CA, CO, FL, GA, IL, KY, LA, MD, MA, MN, MO, NE, NJ, NM, NY, OH, OK PA, RI, TN, TX, UT, VA, WY, WI, and WV and the countries of BELGIUM, BRAZIL, CZECH REP
- Date initiated
- 2011-11-03
- Date posted
- 2011-11-21
- Date terminated
- 2013-01-15
- 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 |
|---|---|---|
| SUPER SHEATH INTRODUCER SHEATH (K052557) | Togo Medikit Co., Ltd. | 2006-01-17 |