8F Plastic Dignity Low Profile CT Port W/Pre-Attached ChronoFlex Polyurethane Catheter
This recall has been terminated (originally issued November 22, 2017).
- Recall Initiated
- November 22, 2017
- Terminated
- July 11, 2018
- Recall Number
- Z-1271-2018
- Quantity
- 24 Eaches
- Firm Location
- Harleysville, PA
- Official Source
- View on FDA website ↗
Reason for Recall
The kit was packaged with the incorrect guidewire. The label indicates the kit contains a marked guidewire. The kits were packaged with an unmarked guidewire.
Distribution
CA, AR. AL
Lot / Code Info
Lot/Serial/Model/Catalog Numbers/Exp. Date: Lot # MJKK420; serial # N/A, Catalog # MRDP80PLN, Exp. Date 2022-01-09; UDI#- 884908110449
Root Cause
Mixed-up of materials/components
Action Taken
Recall notification was issued, by mail to the customers on November 22, 2017. This notification requested that customers review inventory and return all un-used affected product after quarantine. Questions or concerns can be directed to 215-256-4201/
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