Recall Z-2424-2015 ยท DWS Instruments, Surgical, Cardiovascular
International Biophysics Corp.
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.
| Date | Aug 19, 2015 (initiated Aug 7, 2015) |
| Status | Terminated |
| Reason | It was discovered that the heat seal placed onto sterile pouches may not meet strength acceptance criteria. |
| Root cause | Packaging process control |
| Action | The recalling firm began notifying their affacted customers on 7/2/2015 |
| Quantity | 771 units |
| Distribution | Worldwide - United States Nationwide and the countries of: Germany, Norway, Turkey, Chile, Pakistan, and Republic of South Africa |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.