Recall Z-1454-2017— CORENTEC CO., LTD
Class II · Terminated
Class II FDA medical device recall by CORENTEC CO., LTD, initiated 2017-02-27, terminated 2017-05-11. It names one FDA 510(k) clearance: K162127. Product: Bencox Mirabo PE Liner 36/44 Model Number: H1.L61.3644, UDI: 8806373852343. Reason: Lot may contain the wrong instruction (Instruction for Chinese customer) instead of correct US instructions for use..
- Recalling firm
- CORENTEC CO., LTD
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2017-02-27
- Terminated
- 2017-05-11
- Firm location
- Seobuk-gu, Cheonan-si, N/A, Korea (the Republic of)
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
Bencox Mirabo PE Liner 36/44 Model Number: H1.L61.3644, UDI: 8806373852343
Reason for recall
Lot may contain the wrong instruction (Instruction for Chinese customer) instead of correct US instructions for use.
Data sourced from openFDA. This site is unofficial and independent of the FDA.