Recall Z-1370-2018— Teleflex Medical Europe Ltd
Class II · Terminated
Class II FDA medical device recall by Teleflex Medical Europe Ltd, initiated 2018-03-15, terminated 2020-10-05. It names one FDA 510(k) clearance: K841035. Product: Baker Jejunostomy Tubes: Product Code Equivalent Code (a) 655300160 655316 (b) 655500200 655520. 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..
- Recalling firm
- Teleflex Medical Europe Ltd
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-03-15
- Terminated
- 2020-10-05
- Firm location
- Athlone, Ireland
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
Baker Jejunostomy Tubes: Product Code Equivalent Code (a) 655300160 655316 (b) 655500200 655520
Reason for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.