Device product
IBC Vascular Loop Catalog Number CH111, CH112, CH113, CH114, CH115, CH116, CH118 Product Usage: The IBC Vascular Loop is a single-use, disposable loop used in occluding, retracting, and identifying arteries, veins, tendons, and nerves in surgical procedures.
Z-2424-2015
Product summary
- Event
- Event 71911
- Status
- Terminated
- Classification
- Class II
- Quantity
- 771 units
- Official record key
device-enforcement:Z-2424-2015
Official wording
Reason: It was discovered that the heat seal placed onto sterile pouches may not meet strength acceptance criteria.
Code information: 031715-3418, 050815-3513, 052115-3540, 033015-3435, 052115-3542, 031615-3417, 050815-3514, 052115-3543, 033015-3436, 050815-3515, 060915-3578, 041715-3478, 033015-3437, 050815-3516, 052215-3545, 042015-3482, 052115-3541
Distribution pattern: Worldwide - United States Nationwide and the countries of: Germany, Norway, Turkey, Chile, Pakistan, and Republic of South Africa
Derived failure modes
-
Unknown
It was discovered that the heat seal placed onto sterile pouches may not meet strength acceptance criteria.