Recall Z-0899-2018 ยท GBX Catheter, Irrigation
Degania Silicone, Ltd.
Silicone Fluted Round Drain 24Fr (hubless) & Connector, Sterile. Catalog Number JP-2234. Used for the drainage of body fluids for surgical use.
| Date | Feb 20, 2018 (initiated Oct 3, 2017) |
| Status | Terminated |
| Reason | Sterile pouches are missing labels on them. The boxes themselves are properly labeled. The issue is related to the production lot P1607442 only. |
| Root cause | Error in labeling |
| Action | An Urgent Medical Device Correction letter, dated October 03, 2017, was sent to the customer. The letter identified the affected device and the reason for the recall. The letter instructed the consignee to check its stock in order to remove all mislabeled product from the market and eliminate potential risk of misuse. The customer was instructed to return the completed Confirmation Sheet to Degania Silicone, as well as any unlabeled product. Questions regarding the recall should be directed to Katia Kayam, Customer Complaints Officer at Katia@ds-il.com. |
| Quantity | 4,000 units |
| Distribution | US Distribution to Puerto Rico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.