RecallRadar

FDA Device recall Z-1454-2017

Bencox Mirabo PE Liner 36/44 Model Number: H1.L61.3644, UDI: 8806373852343

On 2017-03-22 the FDA classified a Class II recall of Bencox Mirabo PE Liner 36/44 Model Number: H1.L61.3644, UDI: 8806373852343 by Corentec, citing lot may contain the wrong instruction (Instruction for Chinese customer) instead of correct US instructions for use.

Read the official FDA Device notice

AgencyFDA Device
Recall numberZ-1454-2017
ClassificationClass II
Statusterminated
Initiated2017-02-27
Published2017-03-22
Last updated2026-09-13 11:54 UTC
CompanyCorentec
DistributionPA

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.

Identifiers

code_infoLot Number: 10AFFQ21 Expiration Date: 2021-11-28

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1454-2017%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.