Z-0733-2017 Class II Terminated
FDA device recall Z-0733-2017 was initiated by Cook Inc. on Nov 28, 2016 and is designated Class II. Reason for recall: Cook Medical has received reports of the trays containing the incorrect needle, which in some cases could result in the inability to pass a wire guide through the needle. Potential adverse events… The recall status is terminated (terminated Sep 6, 2017). Affected quantity: 99 units.
Recall Details
- Product Type
- Devices
- Report Date
- Dec 21, 2016
- Initiation Date
- Nov 28, 2016
- Termination Date
- Sep 6, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 99 units
Product Description
Cook Spectrum Minocycline/Rifampin Impregnated Double Lumen Central Venous Catheter Tray Cook Spectrum Minocycline/Rifampin Impregnated Triple Lumen Central Venous Catheter Tray
Reason for Recall
Cook Medical has received reports of the trays containing the incorrect needle, which in some cases could result in the inability to pass a wire guide through the needle. Potential adverse events that may occur as a result of utilizing needles of incorrect size include delay in treatment, which could be critical in an emergent situation. There have been no reports of illness or injury associated with this issue.
Distribution Pattern
AZ CA DC GA IL LA MN MS NC NV NY OK PA TN TX WI
Code Information
catalog number: C-UDLMY-401J-ABRM-HC-FST Lot 6498570 catalog number: C-UTLMY-501J-ABRM-HC-FST Lot 6501835 Exp date 9/30/2018
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0733-2017
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026