Recalls / —
—#33552
Product
Percutaneous Transluminal Coronary Angioplasty system in sterile pouch.
- FDA product code
- LOX — Catheters, Transluminal Coronary Angioplasty, Percutaneous
- Device class
- Class 2
- Medical specialty
- Cardiovascular
- Affected lot / code info
- 1) PMA # P790017/S79 2) Device Listing Number 2112641 3) Facility Registration number 2953200 4) lot codes 44DOE015, 44DOE016, 44DOE019, 44DOE022, 44DOE023, 44DOE020, 44DOE024, 44DOE025, 44DOE026, 44DOE021, 44DOE029, 44DOE032 5) Item numbers NCS2506ZP, NCS3016ZP, NCS2511ZP, NCS3516ZP, NCS3511ZP, NCS3521ZP, NCS3006ZP, NCS3011ZP, NCS2516ZP, NCS4006ZP, NCS4011ZP, NCS3021ZP
Why it was recalled
medical device for which sterility may be compromised because of improper seal.
Root cause (FDA determination)
Other
Action the firm took
A notice letter was sent to all 40 consignees, and phone contact is made. A physical visit to the account would be conducted to collect affected product.
Recalling firm
- Firm
- Medtronic Vascular
- Address
- 3576 Unocal Pl, Santa Rosa, California 95403-1774
Distribution
- Distribution pattern
- Product was distributed to 40 hospitals
Timeline
- Recall initiated
- 2004-06-08
- Posted by FDA
- 2004-07-20
- Terminated
- 2004-11-09
- Status
- —
Source: openFDA Device Recall endpoint. Recall record ID #33552. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.