Device product
Baker Jejunostomy Tubes: Product Code Equivalent Code (a) 655300160 655316 (b) 655500200 655520
Z-1370-2018
Product summary
- Event
- Event 79579
- Status
- Terminated
- Classification
- Class II
- Quantity
- 200 units
- Official record key
device-enforcement:Z-1370-2018
Official wording
Reason: These products contain latex, but the following statement is not included on any level of product packaging: Caution: This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions.
Code information: (a) 655300160 655316 Batch Numbers 13EG28 13HG23 (b) 655500200 655520 Batch Numbers: 13EG28
Distribution pattern: US Nationwide Distribution
Derived failure modes
-
Unknown
These products contain latex, but the following statement is not included on any level of product packaging: Caution: This Product Contains Natural Rubber Latex Which May Cause Allergic Reactions.