Boston Scientific, Imager II Angiographic Catheter, (Outer Carton Label): UPN M001315081, 5 Fr, 100 cm, Catalog No. 31-5
FDA device recall Z-0279-2008 · posted 2007-12-06 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corporation
- Reason for recall
- Mislabeled: Units within the identified lot/batch were incorrectly labeled as 5F on the outer carton and pouch when the product was actually a 4F device.
- Action taken
- Boston Scientific sent an Urgent Medical Device Recall -- Immediate Action Required letter to consignees on 10/12/07. The letter described the product and the mislabeling problem (labeled outer carton and pouch as 4F when they are actually 5F devices). The firm recommended segregating the affected product and to return it to Boston Scientific PLEASE NOTE: The firm's recall letter incorrectly addressed the mislabeling of this product recall. The mislabeling involves the labeled outer carton and pouch were labeled as 5F when the device enclosed in the pouch was a 4F device.
- Root cause
- Packaging
- Status
- Terminated
- Product code
- DQO
- Quantity affected
- 14 boxes each containing 5 Units
- Distribution
- USA only including states of NJ, CA,TX,AZ
- Date initiated
- 2007-10-12
- Date posted
- 2007-12-06
- Date terminated
- 2007-12-19
- Location
- Natick, MA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| IMAGER II ANGIOGRAPHIC CATHETER (K050863) | Boston Scientific Corp | 2005-09-02 |
| IMAGER II ANGIOGRAPHIC CATHETER (K011664) | Boston Scientific/Medi-Tech | 2001-09-07 |