Recalls / —
—#92408
Product
Hemashield Finesse Ultra-thin Knitted Cardiovascular Patch.
- FDA product code
- DSZ — Pacemaker Battery
- Device class
- Class 3
- Medical specialty
- Cardiovascular
- 510(k) numbers
- K962342
- Affected lot / code info
- xxx
Why it was recalled
Various Hemashield products may develop glycerol droplets on the inner blister of the package if not stored under proper conditions, which could lead to the prolongation of surgery and potentially compromise patient safety.
Root cause (FDA determination)
Package design/selection
Action the firm took
Letters were sent by Federal Express commencing July 12, 2010. Distribution has to be obtained from Boston Scientific. Questions are directed to the local Sales/Service Representative, or to the firm's Customer Service at 1-888-880-2874.
Recalling firm
- Firm
- Maquet Cardiovascular, LLC
- Address
- 45 Barbour Pond Dr, Wayne, New Jersey 07470-2094
Distribution
- Distribution pattern
- Nationwide Distribution.
Timeline
- Recall initiated
- 2010-05-24
- Posted by FDA
- 2010-07-22
- Terminated
- 2011-07-14
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #92408. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.