Recalls / —

—#50492

Product

Boston Scientific SpyGlass Light Cable Reference Number: 4621 UPN M00546210

FDA product code

EQH — Source, Carrier, Fiberoptic Light

Device class

Class 1

Medical specialty

Ear, Nose, Throat

510(k) numbers

K864387

Affected lot / code info

Lot Number: 355R

Why it was recalled

Light Degradation in transmission-A film may deposit on the front face and limit transmission of light

Root cause (FDA determination)

Other

Action the firm took

Boston Scientific notified accounts by letter dated 2/1/07 requesting return of product.

Recalling firm

Firm

Boston Scientific Corporation

Address

1 Boston Scientific Pl, Natick, Massachusetts 01760-1536

Distribution

Distribution pattern

Nationwide Distribution --- including states of CA, CO, FL, OH, MA, MN, MO NY, PA, SC,TX, and WA .

Timeline

Recall initiated

2007-02-07

Posted by FDA

2007-03-31

Terminated

2007-11-15

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #50492. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.