Data Foundry

Medical device recalls 2016

Cook Spectrum Minocycline/Rifampin Impregnated Double Lumen Central… — Class II medical device recall Z-0733-2017

Terminated recall by Cook Inc., reported 2016-12-21, distributed in AZ, CA, DC, GA, IL, LA, MN, MS…. Cook Medical has received reports of the trays containing the incorrect needle, which in some cases could resu

Recall numberZ-0733-2017
Product typeMedical device
ClassificationClass II
StatusTerminated
Voluntary or mandatedVoluntary
Recalling firmCook Inc., Bloomington, IN, United States
Recall initiated2016-11-28
Classified2016-12-12
Reported by FDA2016-12-21
Terminated2017-09-06
DistributedAZ, CA, DC, GA, IL, LA, MN, MS, NC, NV, NY, OK, PA, TN, TX, WI
Quantity99 units
Lot numbers6498570, 6501835
Model numbersC-UDLMY-401J-ABRM-HC-FST, C-UTLMY-501J-ABRM-HC-FST
Expiration dates2018-09-30

Product

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0733-2017. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.