Boston Scientific Easy Core" Biopsy System, 18 ga. x 10 cm, REF 43-452, UPN MOO1434521, Sterilized with ethylene oxide g
FDA device recall Z-0328-2009 · posted 2008-11-28 · Terminated
Recall details
- Recalling firm
- Boston Scientific Corporation
- Reason for recall
- Boston Scientific Corporation initiated a recall of its easy Core" BIOPSY SYSTEM due to difficulty cocking or arming the cannula latch on the device. This difficulty may result in an inability to use the device.
- Action taken
- Consignees were sent a "Boston Scientific Urgent Medical Device Recall" letter dated October 21, 2008. The letter was addressed to The Hospital Field Action Contact. The letter described the problem and products being recalled. The letter stated that it was very important that the attached product table be used carefully and consider both inner and outer packaging product codes when searching for affected/recalled product as the UPN numbers on the inner and outer labeling are different. Requested to discontinue use of product, identify, and segregate and return affected products to BSC. Letter also requested to complete and return the Reply Verification Tracking Form.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- FCG
- Quantity affected
- 3808 total for all products
- Distribution
- Nationwide Distribution --- including states of AL, AZ, AR, CA, CT, FL, GA, ID, IL, IN, IA, KS, KY, LA, ME, MD, MA, MI, MN, MS, MO,MT, NE , NV, NH, NH, NM, NY, NC, OH, OK, OR, PA, RI, SC, SD, TN, TX,
- Date initiated
- 2008-10-07
- Date posted
- 2008-11-28
- Date terminated
- 2011-12-10
- 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 |
|---|---|---|
| EASY CORE BIOPSY SYSTEM (K040893) | Boston Scientific Corp | 2004-05-06 |